Validation Resume Samples

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R Shields

Ronny

Shields

761 Morton Shoals

Philadelphia

+1 (555) 919 4617

761 Morton Shoals

Philadelphia

Phone

p +1 (555) 919 4617

Experience Experience

Phoenix, AZ

Validation Coordinator

Phoenix, AZ

Abernathy, Renner and Kuvalis

Phoenix, AZ

Validation Coordinator

Work with external manufacturing companies, suppliers, and service providers to ensure meeting supply demand in timely manner
Manages vendor generated validation protocol packages from review to final report approval
Provide technical support within the site for Manufacturing and Supply operational areas
Manages and reviews validation master plans and reports
Design and create validation protocols & reports for cleaning validation, process validation, media fills & air system qualifications
Develops or revises validation SOPs
Manages requalification schedule and requalification events in database

New York, NY

Validation Associate

New York, NY

Schaefer Inc

New York, NY

Validation Associate

Provide project management oversight for validation activities related to products and facilities, utilities, equipment (FUE) including cleaning, steaming and computer systems
Developing validation plans for specific system implementation projects
Execute (protocol generation, execution, and final package preparation) validation activities related to the implementation of process, cleaning, steaming and facilities, utilities, equipment (FUE) changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions
Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's
Lead and represent Validation in multi-departmental meetings & project teams
Identifies and implements improvements to the QA Validation systems
Participation in the change control program for modifications to qualified systems

present

Phoenix, AZ

Lead Validation Engineer

Phoenix, AZ

Hilll, Kuphal and Breitenberg

present

Phoenix, AZ

Lead Validation Engineer

present

Develop automation in Python, execute test cases, and analyze/debug failures for functional, and performance tests
Execute and validate performance and scaling tests for networking device
Work with ASIC and SW development teams to report and resolve issues identified
Perform project management functions to plan and coordinate prototype operation
Collaborate with Process Development to ensure successful process development and technical transfer to Manufacturing. (10%)
Work together with the design engineer in setting-up DoE to debug and optimize product performance during evaluation
Lead and provide support to manufacturing to ensure testing is executed as intended. (10%)

Education Education

Bachelor’s Degree in Electrical Engineering

University of Southern California

Bachelor’s Degree in Electrical Engineering

Skills Skills

Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations
Strong attention to detail
Excellent written and verbal communications, including technical writing. Microsoft Office Software, with MS Project
Working knowledge of Six Sigma and/or Lean manufacturing tools
Ability to work in and promote a team environment
Ability to lead and influence people
Practical experience with quality risk management and risk based validation approaches
Excellent written and oral communication and leadership skills
Ability to define problems, issues and opportunities, analyze data, establish facts, and draw valid conclusions from various datasets
Knowledge of US and International pharmaceutical manufacturing regulations

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Data Validation Research Manager Resume Examples & Samples

Managing the development and maintenance of the consumer data methodology and Point of Satle (POS) projection methodology
Routinely interacting with Business Unit and Operations Management
Partner with Client Development, Retail Business Group, Panel, and Operations teams to achieve goals
5+ years of experience in data collection and analytical processes
Strong presentation skills to both small and large groups

Lead Analyst Consumer Risk Modeling & Validation Resume Examples & Samples

Review, develop, validate and manage quantitative model review process for quantitative modeling governance (design, development, validation, calibration, documentation, approval, implementation, monitoring and reporting), in collaboration with Risk Modeling Leader
Lead modeling data capture, gathering, mastering and maintenance in support of modeling databases, in collaboration with platform resources
Manage model supporting data warehouses in terms of accuracy and completeness; understand data and process structures from System of Record to Data warehouse to ensure accuracy and precision of data used for modeling, reporting and analysis
Drive standardization of processes that ensure timely generation and retrieval of reporting and risk analytics data, including support of model management framework
Incorporate operational definitions and conceptual system designs to create algorithms that meet business reporting and analytics needs
Strong business finance acumen, especially in Financial Services Industry
Demonstrated experience in consumer statistical model lifecycle management, including proficient level of expertise with at least one statistical modeling language/utility SAS (or equivalent) proficiency and expertise building and implementing routines for data transformation
Demonstrated strong SQL skills and experience delivering SQL code and supporting physical database designs
Strong knowledge of Consumer finance
Demonstrated ability to lead and support projects from beginning to end
Operational understanding of and experience with Model Risk, and balancing sophistication with simplicity (Ockham's Razor)

Process & Data Validation Associate Resume Examples & Samples

Work with Regulatory Policy to understand Basel requirements and evaluate the appropriateness of rules application to specific capital process
Work closely with subject matter experts within relevant groups; understand the current capital process and relevant dependencies
Figure out the best way to verify process effectiveness, obtain relevant data and carry out the analysis
Discuss the results with relevant groups, exercise sound judgments and draw independent conclusions
Figure out the remediation plans with process owners and senior management
Document and present validation results to senior management and regulators
Coordinate with other firm-wide validation teams to understand how our processes fit into the overall flow data and checks
Problem solver, big picture thinker who does not lose sight of details, passionate about learning, process building orientation, excellent communicator!
5+ years of working experience in financial industry
Can demonstrate excellent understanding of Credit or Market risk processes where the candidate has prior experience
Awareness of Basel rules and familiarity with some capital process is very helpful
Ability to construct SQL queries to perform data mining and analyses and to use advanced Excel functions and Pivot tables
Ability to work thoughtfully and independently and manage multiple projects
Excellent follow through skills
Experience of interacting with regulators, Master’s degree, CFA or FRM

Credit Validation Resume Examples & Samples

Interpret Basel requirements and evaluate the appropriateness of rule application
Verify credit processes pertaining to regulatory risk-based capital estimates and credit risk management for their consistent practice over time and maintenance of audit trail
Identify and extract key data elements relating to credit processes and evaluate the accuracy, timeliness and reliability of credit data by data mining and analyses
Discuss test discrepancy, exercise sound judgments and draw independent conclusions
Socialize observations and remediation plans with process owners and senior management
Document and present validation results to senior management
Interact with all levels of subject matter experts within the Credit Department to carry out validation activities
Coordinate with other firm-wide validation teams for front-to-back process reviews
5+ years of working experience in financial industry
Knowledge of trading and lending products bearing credit risk and respective risk control mechanisms
Knowledge of Basel rules pertaining to credit risk capital calculations
Solid analytical and investigative skills to identify possible root causes
Ability to construct SQL queries to perform data mining and analyses and to use advanced Excel functions and Pivot tables
Inquisitive mindset and ability to exercise independent judgments and challenge established norms
Experience of interacting with regulators
FRM certification or MBA degree

Manager, Process Validation & Effectiveness Resume Examples & Samples

Authority to communicate priorities and planning initiatives with other work groups, and provide an interpretation of the implications of factors adversely affecting these priorities and their impact to the achievement of business goals and objectives
Authority to provide input in the planning and establishment of priority of various process improvement and simplification initiatives
Authority to create relationships with stakeholders
Authority to implement strategies to optimally position change to stakeholders; actively champion advantages of change associated with the project objectives
Authority to identify stakeholder strategic issues that emanate from the process improvement and simplification initiatives
Authority to initiate communications with stakeholders
Advisory
Authority to evaluate issues and develop solution-based options; inform, and communicate recommendations to key relationships
Authority to provide advice and counsel to other work groups that could resolve a diverse range of issues/problems
This role has the authority to examine whether business strategies and processes meet the requirements and needs of the business
Issue Resolution - Resolve a diverse range of related issues/situations/problems arising from process driven initiatives
Market Risk stakeholders (i.e., Capital Markets trading line of business executive and traders, Capital Markets Operational Risk, Finance, Technology Development etc.) of business and/or operational process changes
Market Risk workgroups (i.e. Risk Oversight, VaR Production, Risk Models, etc.) of the status of change initiatives
Consult with governance committees for direction on resolution of issues that have significant time and/or budget implications
Receive service from stakeholders with respect to engagement in change management activities (i.e., requirements gathering, testing, etc.)
Work with other areas of Market Risk (e.g. Risk Oversight, Risk Models, VaR Production) in order to understand business objectives, translate business requirements into process improvements, and ensure alignment of priorities as they relate to implementing change
Be informed of the performance against objectives by business partners, and to require remediation when performance is sub-optimal
Be informed of incremental progress by groups planning, analyzing or under-going change
If the incumbent is not satisfied with the activities of the other work groups, the incumbent has the authority to persuade / influence any required changes and/or escalate to the issue to the leaders of Risk Infrastructure
4 to 6 years of related work experience, preferably in a financial institution
Strong financial services industry background with Capital Markets experience, particularly over-the-counter derivatives for all asset classes
Strong knowledge of risk management and trading room operations, particularly market risk, Basel/OSFI regulatory requirements for trading book products, and best practices as related to credit processes
Strong knowledge in business processes, organizational design or change management to enable effective recommendations of change without paralyzing the current state yet creating a practical strategic course for the future
Strong understanding and experience with project management or external consulting
Strong understanding and awareness of the use of technology in regards to various business applications
Certification in one or more of Quality and Productivity Improvement Methodologies (e.g. Lean Six Sigma Master Black Belt)
Graduate degree, MBA or equivalent general business experience
Strong oral and written communication skills, including solid interpersonal skills (especially “Listening Skills”)
Strong facilitation skills for leading meetings, making decisions and resolution of conflicts related to definition, design,

Cash Equity Trade Validation & Control Analyst Resume Examples & Samples

Post execution trade management
Research and resolution of all client and desk related ad-hoc queries
Ability to multi-task in a fast paced, high pressure, high volume environment

External Validation Over The Counter Confirmations Analyst Resume Examples & Samples

Exposure to OTC Fixed Income and FX vanilla and structured products with possible exposure to other asset classes
Drafting bespoke confirmations using the 2002 and 2006 ISDA definitions for Fixed Income products, which include but not limited to IRS Swaps, Swaptions, Inflation Swaps, Cross Currency Swaps, Bond TRS and Structured Interest Rate Swaps
Work and partner with Credit Suisse vendor in Pune to streamline drafting processes. Identify and implement process changes to drive efficiency and capacity saves
Work on timely confirmations and ad-hoc projects to drive efficiency and streamline processes within the paper drafting space
Collaborating with internal peers and stakeholders to deliver paper confirmation infrastructure and process changes
Conduct testing prior to IT enhancement releases

Validation Lead IT Systems Test Consultant Resume Examples & Samples

Assume overall responsibility for the management of the data warehouse/business intelligence technical interfaces. Under general direction, consult with line of business/development organizations to create development/test processes
Devise and/or modify procedures to solve the most complex technical problems related to testing, performance, capacity and limitations, operating time, and form of desired results
Create detailed test specifications from which test scripts will be written
Manage testing and/or full development efforts for projects
Develop test strategies and processes. Competent to work at the highest technical level of all phases of applications testing activities
Work with vendors monitoring and reporting on quality issues
Fifteen years of experience in testing, quality assurance and project management processes
Experience equivalent to BB&T Certified Quality Analyst
Demonstrated proficiency in basic computer applications such as Microsoft Office software products
Ability to direct other team members and train others
Experience in the following

Hardware Validation, Intern / co Op Resume Examples & Samples

Drive hardware optimizations by creating hardware, thermal, and mechanical test plans for server hardware
Execute tests according to plan, while keeping a through procedural record and data log
Create automated test infrastructure, through the use of scripted languages and remotely controlled test equipment
Diagnose and root cause component failures

Manager Test & Validation Resume Examples & Samples

Build the test and validation team
Ensure all functional, environmental, reliability, and safety requirements are met by the products
Compliance testing to UL, IEC, FCC, and other applicable standards
Serve as a resource to the rest of the team on safety standards
Oversee the creation of automated test equipment
Create, maintain, communicate, and present the validation schedule
Identify creative ways to overcome obstacles and meet the schedule despite setbacks
Ensure the availability of test equipment, chambers, and 3rd party test labs to meet the schedule
Drive root cause analysis of failures and participate in finding solutions
Drive test analysis and documentation best practices

Computer Sys Validation Spec Resume Examples & Samples

Participate on Software development, and Business development Agile project teams to create, revise and execute validation documentation for information systems to meet required business needs
Periodically review, revise and streamline current in house CSV methodology to meet sound business practices for projects participating in regulated environments
Generate validation documentation (requirements specifications, functional specifications, configuration specifications, risk assessments, validation plans, IQ, OQ, PQ (Installation, Operational, Performance and Qualifications) and related reports, and validation summary reports, etc.) using defined procedures
Review and revise system related SOP’s (Standard Operating Procedures), WO’s (work orders), QOPs (Quality Operating Procedures), CSV and all other department standards and compliance documentation as applicable
Assist with qualification execution (IQ, OQ, PQ) of system validations as assigned
Provide updates and interact with key stakeholders involved with system qualification (e.g. Quality and Compliance, SCS, RA’s, PM’s, QC, Product Owners etc.)
Provide Computer System Validation (CSV) training for all key CSV stakeholders
Ensure that the validation activities identified in the SDLC are implemented and documented through protocols for design, installation, operations, software and performance qualifications
As applicable perform criticality analysis for initial or on- going validation/qualifications based on quality standards and regulatory requirements in conjunction with RTIS business needs
Plan and structure validation activities for systems development in coordination with your direct management and Quality and Compliance
Develop a project validation summary report at the end of projects based on validation reporting template requirements
Bachelor's degree in Engineering, Computer Science, Life Sciences or applicable experience with minimum of three to five years of experience in the Life Sciences validation field
Agile/Scrum methodology preferred
21 CFR Part 11 experience
Strong organizational and time management skills, with exceptional attention to detail
Works effectively with the ability to collaborate in a team environment, excellent reasoning and negotiating skills
Results oriented and ability to meet firm deadlines while working in a complex and variable environment
Requires knowledge of the current GMPs and FDA requirements
Requires critical and analytical thinking skills
Proficient with Microsoft Office and database tools

Product Test Carrier Validation Test Lead Resume Examples & Samples

10+ years of experience in sw validation / sw development / project
5+ years testing experience in Android mobile platform environment and
1+ years of carriers certification testing is a plus

SW / HW Developer & Validation Eng Resume Examples & Samples

Programming experience with high level programming languages (such as C/C++/C#, JAVA*)
Good communication skills, verbal and written
Fluent in English language
Reliable working under pressure, changing conditions and new technologies
Comfortable and confidence working remotely with multiple sites in a multicultural environment
Proactive attitude
Knowledge in scripting languages (such as Perl, Shell*), UNIX (Linux) at user level, and hardware description languages (such as VHDL, Verilog, System Verilog*) and Specman* is a plus
Experience with RTL simulation and validation tools (VCS, Modelsim, other), is also a plus
Experience with industry standard IO interfaces like DDR2, DDR3, PCIe, SATA, and USB; and/or digital communication protocols is a big plus

SW Validation Student Engineer Resume Examples & Samples

Knowledge in wireless protocols
Android/Linux knowledge can become good advantage
Testing experience from previous jobs is required
C# coding knowledge is required. 5. Currently studding toward degree in SW Engineering or Electrical Engineering
Minimum 2 years till end of studies
Ability to work 3-4 days a week

IOT Validation Engineer Resume Examples & Samples

Be the validation expert for testing use cases that span many segments such as Automotive, Print Imaging, Visual Retail, Industrial etc
System level verification of new and legacy functionality in a customer like configurations
Represent validation team in silicon, system and software architecture forum in Product PLC
Debug of customer software and/or hardware through the use of advance tools and methods

Validation Application Engineer Resume Examples & Samples

Be proficient in the usage models of one or more SVE's validation tool stacks (content, automation, debug, lab infrastructure) for one or more validation disciplines (SV, OSV, EV, PPT)
Have expert scripting skills such as python and bash
Have successful industrial experience in platform or system integration, testing and debug

IP / SOC Validation Engineer Resume Examples & Samples

Close interaction with product architecture, logic design, circuit/structural design, design automation, post-silicon validation and manufacturing test development teams to ensure high quality design validation and product delivery
A self-starter with the ability to assume leadership roles
Experience with Intel Front-End tools and Validation methods
Strong hands-on experience with state-of-the-art and industry-standard dynamic verification tools, requirements, and applications like VCS/VCS-MX, Specman, formal verification tools and flows
Strong background in unit level validation environment development, test plan generation and test case implementation for the verification of design block(s)
Strong ASIC and/or SoC design experience
Knowledge of DFx techniques & methodologies
Experience with industry standard development tools and methodologies

Platform Validation Engineer Resume Examples & Samples

Must have a BS or MS degree in Software, Computer, or Electrical Engineering
Minimum 3 months experience in C/C++ development skills (or equivalent)
Minimum 3 months experience in OS knowledge (Windows, Linux, or VMware ESX)
Minimum 3 months experience in Knowledge of software and/or hardware testing and tools (ITP*, LA*, OS debugger)
Minimum 3 months experience in Scripting skills (Python)
Knowledge of Intel's CPU and chipset architecture

High Performance Compute System Validation Engineer Resume Examples & Samples

Bachelor's degree in Engineering (Computer Systems Engineering or Electrical Engineering or Computer Science) or equivalent, plus at least 5 years of relevant experience, including
Ability to review/understand C/C++/Assembly programming
Excellent debugging/problem solving and time management skills
Good knowledge of computer architecture, system network architecture, platform architecture, and validation architecture
InfiniBand or another HPC interconnect is strongly desired
Willingness to do detailed documentation
Self-motivated with the initiative to work independently as well as with a team
Ability to work successfully in a multi-site team environment

HPC System Validation Engineer Resume Examples & Samples

Understand the hardware and software architecture of next generation and current Intel based HPC systems
Create system level test plans and validation strategies
Engage with the ingredient teams to understand their validation plans. This can include the fabric, storage, I/O, compute, and front end systems that make up a large HPC installation
Lead and participate in pre-Si and post-Si validation efforts
Debug system issues at scale
Bachelor's degree in computer science (or relevant field) with at least 4 years work experience or a Master's degree in computer science (or relevant field) with 2 or more years of work experience
Familiarity with HPC software and hardware architectures
Strong programming skills in C and a scripting language, i.e. Python, Perl
Strong Validation experience in HW and/or SW including lower level debugging
Solid written, verbal and presentation skills for expressing complex ideas and initiatives to audiences of varied technical skills
Experience with debug of system HW/SW issues on large HPC clusters
Experience in developing validation test content or diagnostics for cluster HW and SW
Experience with cluster interconnect fabric and software stacks
Experience with HPC system management solutions
Silicon or low level SW debug experience
Experience with Lustre, IO systems

System Solutions Validation Engineer Resume Examples & Samples

Good understanding of Intel Architecture, especially on Atom based SoC IA North Cluster, South Cluster
Good understanding of Industrial Specification for various Display technology: HDMI, DP, eDP, and or specific implementation like Mipi interfaces
Good understanding of Industrial IO interfaces like PCIe, USB, SATA, SD/SDIO/eMMC, LPE/SSP, CAN, Zigbee, Serial Port, etc
Good understanding of Linux OS architecture at the kernel, driver in relation to code implementation for Intel SoC IA
Good understanding of Linux application implementation at the app, lib layer for Media (Video+audio), audio
Good familiarity of porting code implementation among various Linux flavor Fedora, uBuntu, Yocto, Tizen, etc
Good familiarity with Shell Scripts, Python Scripting to automate codes execution at the application layer
Good team work mentality to work in a team and win as a team while being a strong individual contributor that strengthen the overall team
A mindset that is nimble, willing to adapt & pick up new skill set at all aspects of a System consisting of HW & SW
Good mentality to always correlate validation content value to a usage model thru tangible indicator obtain thru Profiling of a system & establish coverage on SoC health in achieving the desired usage model
Has a proven track record of delivering quality System validation, Compatibility Validation, System/Platform Integration Validation, and or any other relevant validations
Has a proven track record of delivering quality innovation as indicated based on impactful solutions, Invention Disclosure(Patent) filed, technical papers(DTTC, Validation Summit, etc), etc

Bios Validation Engineer Resume Examples & Samples

Planning, developing and executing validation tasks to BIOS DV activities
Investigating and adapting appropriate existing validation tools to BIOS DV group
Planning, developing and executing code and tools to help the group keeping Software Best Practices
Designing, developing and debugging BIOS Validation Tools and SW
Participating in key silicon product development and technical teams
Designing, developing and debugging BIOS Validation Tools for pre and post silicon
Providing pre and post silicon support
Engaging with various internal cross-team validation organizations, the technical enabling group, and several outside Independent BIOS Vendors (IBV) and/or Original Equipment Manufacturer (OEM) customers
Develop automated test content
Understanding of Intel Architecture
Strong Java, C++, or C# coding skills and/or knowledge
Scripting Languages knowledge is desired. Example: Python, Ruby, Pearl
Linux Server Admin skills or knowledge
Good software (S/W) architecture and design skills
Fluent in written and spoken English. (90%-100% range)

Platform Validation Engineer Resume Examples & Samples

Playing the crucial role as quality holder in product development team to ensure product quality by supplying solid data of board- and system-level and performance test
Collaborating with CPD HW/SW/System architects and engineers, various validation disciplines, and worldwide marketing teams for constant improvement of validation test philosophy and methodology
Being responsible for training and educating junior validation engineers and help to create a positive and precise atmosphere within validation team
Good understanding (and better hands-on development/validation experience) of Operating System, driver and popular server/PC technologies including PCI/PCI-E, USB, SAS/SATA, i2C/SMBUS, IPMI, BIOS/EFI and DIMM, etc
Proven capability to debug & troubleshoot complex HW/SW issues related to BIOS, OS, Hardware, as well as Hardware-Software interaction
Demonstrated capability to start with use case/experience of technical features, develop technical solutions to validate features, and ensure the final high-quality to the market
Demonstrated capability to work within a team environment facing fast-changing requirements and complicated stakeholders

SSD Validation Development Engineer Resume Examples & Samples

Good oral and written skills
Root Cause Analysis
Bachelor/Masters of Science degree in Electrical Engineering, Computer Engineering or Computer Science
6+ months experience of
Validation and/or debug experience (preferred storage products experience)
SAS, SATA, AHCI, and/or NVMe storage validation / protocol experience
Storage security experience: AES, E2E, DIF, Opal
Supplier or vendor management

SVE Server CPU System Validation Engineer Resume Examples & Samples

Developing & executing test suites for multi-core CPUs
Providing & driving validation and debug requirements into partner teams
Performing debug at the CPU core, chipset, board, and system level
Driving continuous improvement into existing validation test suites & methodologies
An inquisitive and tenacious mindset
Strong ability to multi-task
Minimum of 6 months experience with hardware and software design, coding, and debug skills
Minimum of 6 months experience with computer system architecture
Minimum 6 months experience with digital electronics and logic design
6mths+ experience Windows*, UNIX*, and/or other operating systems
6mths+ experience with C, C++, Linux*, PERL or Python
6mths+ experience with major bus protocols such as PCI Express*, DDR, or QPI
6mths+ experience with 80x86 Assembly language

Client Validation Engineer Resume Examples & Samples

Must possess Bachelor or Master of Science in Electrical Engineering, Computer Engineering, or Computer Science
Minimum of 3 month experience with software/programming languages (i.e. C, C++, Python)
Minimum of 3 month experience of computer architecture and/or processor architecture (Intel IA-32/64 preferred)
Minimum of 3 month experience with installing, and/or operating of commercial OS (Windows, Linux, Apple, Android)
Minimum of 3 month experience in software and/or hardware computer architecture coding, validation, and/or debugging skills

Senior System Validation Engineer Resume Examples & Samples

Education: BS EE/CE with 6+ years or MS EE/CE with 4+ years experience in silicon validation and/or RTL development / validation
Experience with IA and other processor/microcontroller architectures and validation/debug tools (ITP, debuggers, logic analyzers)
Strong system and debug skills
Experience developing and implementing coverage-centric test plans and driving coverage and efficiency improvements within the organization
Experience leading small technical teams in a formal or informal capacity

RTL Validation Engineer Resume Examples & Samples

Design test plan, defining verification architecture, test sequences, coverage matrix, and checking schemes
Using SystemVerilog, OVM/UVM libraries and BFMs to develop a complete verification environment and regression tests
Perform debugging and collaborating with the designers and BFM team to drive bug fixes
Master of Science degree in Electrical Engineering or Computer Science and Engineering
2+ years of experience in RTL verification/development
2+ years of experience in SystemVerilog and Verilog programming
2+ years of experience with modern verification methodology such as OVM/UVM
2+ years of experience in Simulation tools such as Synopsys VCS
2+ years of experience writing perl, shell scripts
2+ years of experience of debug test failure
Experience developing BFMs
Familiar with cache coherence
Familiar with CPU architecture
Familiar with communication protocols such as PCI express, Intel QuickPath Interconnect, etc
Prior experience working with Heterogeneous (FPGA, GPGPU) hardware systems

SW Validation Engineer Resume Examples & Samples

Knowledge of block / file system drivers in Windows
Thorough knowledge of Windows internals
Good knowledge of scripting languages (Python, Perl, Bash) and hardware programming aspects
Prior experience working on storage related products and architectures

Senior Software Integration & Validation Engineer Resume Examples & Samples

Lead the analysis, planning and formulation of strategies and test framework for validating features related to data analytic, security, connectivity and manageability technology
System level verification of new and legacy functionality in a customer like configurations
Be the validation expert for testing use cases that span many segments such as Automative, Print Imaging, Visual Retail, Industrial etc
Represent validation team in silicon, system and software architecture forum at division level
Be the key proponent of modern software techniques and practices like Agile, Continuous Integration, Test Driven Methodology, and high automated testing
Debug of customer software and/or hardware through the use of advance tools and methods
Be a technical mentor for the execution team members and work closely with them to analyze problems and help identify solutions

Software System Validation & Integration Specialist Resume Examples & Samples

Honours degree, Masters or PhD in a software related discipline e.g. Computer Engineering, Electronic Engineering, Computer Science, Physics, Maths etc., or proven programming track record in industry
Candidate must have very strong technical knowledge in software integration/ testing (black box and white box testing) with a min of 6 years' experience. Detailed understanding of the software development processes especially the development of integration, system and interoperability tests
Experience in working in Open Source Initiates, specifically advantageous would be exposure to NFV and SDN open source initiatives and communities e.g. OpenStack, Openflow, OpenDaylight, Quantum, Nox, Ryu, Floodlight etc
Linux development experience, including user and system configuration knowledge
Experience in programming for communications and related protocols, e.g. Ethernet, TCP/IP, ISCSI, Wireless protocols , Switching and Routing
Security applications (IPS/IDS, Firewall, IPSEC, Open SSL, etc.)
Deep knowledge of Virtualisation and Containers - understanding application development on KVM, XEN, QEMU or VMWARE, LXC, Docker
Embedded software experience (SW development or validation), Strong C-coding skills on Linux embedded environments, experience of Intel Architecture/x86 or other multi-core processer technologies. Scripting in at least one of the following: Python, Perl, Java. Understanding of GCC makefiles
Knowledge of operating system (OS) architecture
Experience of Agile development methodologies and/or formal Software development tools/practices
Excellent communication skills and the ability to work as part of a global team
Strong problem solving skills coupled with a strong aptitude to innovate, solutions orientation

Validation Logic Development Team Manager Resume Examples & Samples

Experience in managing system hardware engineering or FPGA development teams
Experience in FPGA/ASIC RTL/Verilog development and/or Verification flows
Experience in cross-site management is an advantage
Taking a leadership position in defining a team's vision, charter and roadmap
Excellent written, verbal, and presentation communication skills, including engagements with customers and partner organizations
Ability to build and manage effective stakeholder relationships, both internal and external
Effective engagement with a multicultural and cross site team environment
Act as a change agent

IOT Validation Architect Resume Examples & Samples

12 + years of hands on experience in validation and/or software that has enabled them to have the following
Software / Platform integration
Programming in C/C++ and/or Python
Platform level debug
Windows kernel / driver debug
Android kernel / driver debug
Test Plan writing
Test execution
Working with 3rd Party SW vendors
Exposure in Connectivity, Security, Manageability, Analytic

IOT SW Validation Engineer Resume Examples & Samples

Strong Programming Skills in C/C++, Bash, Python and Build Scripts. Knowing Assembly is a plus
Broad understanding/exposure to open-source software middleware and application
Good understanding of OS and kernel system and architecture, such as Linux, x86 Architecture and system-level knowledge
Ability to work effectively across a globally diverse team
Methodical debug and problem solving skills
Strong data analysis skills
Test automation and programming skills
Self-starter, self-motivator, and highly adaptable team player
Ability to work in a dynamic environment

Memory Controller Pre-si Validation for Server Designs Resume Examples & Samples

5+ years' experience in logic validation
5+ years' experience programming in an object oriented language such as C++, System Verilog and/or Specman
5+ years' experience with logic simulators
5+ years' experience debugging with logic simulator output

SVE Validation Engineer CG Resume Examples & Samples

Experience with post Silicon Validation
Experience with at least one of the following
SoC Communications
SoC Security Features
Low Power Design/Testing

Pre-si Validation / Verification Engineer Resume Examples & Samples

Defining and enhancing methodologies for pre-silicon validation of high complexity server SOC designs, and improving the overall efficiency and velocity of the pre-silicon validation team
Test bench development, test content development, cluster and full chip validation of RTL, emulation based validation, DFX validation and other aspects of pre-silicon verification of the product(s)
You will need to be very organized with solid understanding of full chip design and integration
BSEE with 7+ years or MSEE with at least 5+ years of applicable experience in the following areas
5+ years of experience in Unit Level Validation Environment Development, Test Plan Generation and Test Case Implementation for the Verification of Design Block(s)
5+ years of experience in ASIC and/or SoC Design
5+ years of experience with Industry Standard Development Tools and Methodologies

Pre Silicon Validation Resume Examples & Samples

Develop a good understanding of CPU product architecture being developed in Client CPU team
Develop/execute pre-silicon validation plans for next generation CPU products
Manage day to day operation for a team of about 5-7 engineers
Perform people management and development for engineers in the above team's 1x1's, focal, dev plans, MBOs (Can mean Management by Objectives or Management buyout, let me know what you are thinking here, I’m thinking the first one), etc
Drive pre-silicon CPU design quality through metrics and indicators such as bug rates, coverage, and test content
Implement Agile/Lean methodologies within the validation team to maximize team efficiency
Knowledge of RTL design and verification languages and tools like Verilog, Perl, x86 Assembly, VCS, OVM
Experience in building teams, employee development and performance and productivity management
Experience and understanding of Coverage driven verification methods, including cluster and full-chip validation methodologies

Bios Validation Engineer Resume Examples & Samples

Candidate should possess a BS, MS or PhD in Computer Engineering or Computer Science
Candidate must have work experience in the following areas
Software development experience involving understanding of computer architectures, microprocessor architectures, virtualization technologies or platform architectures
Tool Development expertise with Strong Programming skills in High Level Languages such as C/C++/JAVA as well as scripting experience in Python, Ruby or Perl
Expertise in Quality Assurance and SW engineering
Proficiency in Validation Methodologies and Continuous Integration processes
Proficiency in verbal and written communication skills

Memory Controller Validation Engineer Resume Examples & Samples

Validate the Memory sub system and DDR/Other memory IO
Master in System Agent architecture, DDR protocol and JEDEC specification
Develop validation test suites for new features, and debugging failures
You should possess a BscMsc degree in Hardware Engineering or Computer Engineering or Computer Science
Experience of 3-10 year of working with IO protocols is a must preferably DDR/other memory protocols

Power & Performance Validation Engineer Resume Examples & Samples

B.Sc in Electrical Engineering, Computer Engineering or Computer Science
3+ years of experience in VLSI/HW design, pre silicon verification or post silicon work (preferably in validation/verification fields)
System understanding is an advantage
Good familiarity with HW debug techniques and lab equipment is an advantage
Previous knowledge on power architecture and power measurements is an advantage
SW understanding and background is an advantage - Opportunity also for SW people looking for a change which utilizes their SW skills

SSD Validation Engineer Resume Examples & Samples

Analyze product features, develop, enhance and execute test plans for enterprise platform compatibility of Solid State Drives. Capture and analyze bus traces, interface with developers to root cause failures. Develop automated test strategy. Generate indicators and communicate status updates across teams
Understanding of Linux and Windows based operating systems, server platforms and device drivers
Experience with high level programming and scripting languages (eg. C, python, perl, batch)
Experienced in validation with strong debug skills
Experienced in developing and implementing test plans and driving coverage and efficiency improvements within the team
Expertise in PCIe protocol and debug, including knowledge of relevant debug tools
SAS, SATA, and/or NVMe storage protocol experience is a plus
Be able to demonstrate success in communicating status, issues, concerns, including development of appropriate indicators
Must have system level knowledge related the platform- CPU, Memory and PCIe storage is a plus. This includes interaction at the hardware, firmware and operating system and software level
Comprehend and articulate validation strategies, plans and status
Must be able to deal with ambiguity and operate with little direction to meet defined goals
Must be able to work with and through others to achieve goals and task completion
Datacenter experience is preferred but not a requirement if other areas are met. Storage experience as it relates to the Datacenter is also a plus

Switching & Server Validation & Automation Engineer Resume Examples & Samples

Designing, coding, and reviewing Python test scripts to ensure high quality SW validation on the latest generation switching and server HW
The modification and design of the main test framework to support OPEN SOURCE standards, new functionality, and complex abstraction layers
Validation and analysis of both manual and automated test cases to ensure quick issue resolution turnaround time
Application of personal switching and networking knowledge to create test plans that fully validate the corresponding hardware
Working closely with key customers and partners to ensure the delivery of a quality product
Bachelors in Computer/Electrical Engineering or equivalent
2+ years of relevant programming in a scripting language (e.g. Python)
2+ years of experience with networking and/or switching (e.g. DHCP, TCP/IP, MAC routing)
Advanced knowledge of how switches work and their terminology
Strong development and programming skills in
Python, TCL/TK, and other UNIX shell scripting languages
Experience using debugging tools (pdb, strace, lsof, ltrace)
Real-world experience with
Test frameworks
Test automation tools
Continuous Integration tools such as Jenkins or BuildBot
Code review tools such as Gerrit or Code Collaborator
Source code version control tools such as Git
Build tools using Make and Linux tool chains
Strong Linux system administration skills
Be able to work well in a team environment, as well as independently

Senior Product Development Engineer DFX Debug & Validation Resume Examples & Samples

Having close partnership with design and product development engineers to deliver Design-for-Test (DFT) solutions
Responsible for Verilog* and/or VHDL test bench creation and/or debug, test writing, Register Transfer Level (RTL) simulation, Gate Level Simulation (GLS), analog simulation, performance validation, VTPSim* (Verilog* test pattern simulator), silicon debug on tester (or on other platform like system level)
Developing, integrating and optimizing test program through characterization and other techniques
Developing or designing test hardware (for example test interface unit)
Managing silicon debug to check out all the structural and functional tests
Qualifying new products and performing detailed test program analysis to ensure product startup with low Defect per Million (DPM), low test time, good yield and meeting other product health indicators before passing over to factory product engineering group for high volume manufacturing
Bachelor's deg in Electronics, Electrical, Microelectronics, Applied Mathematic & Statistics or Computer Engineering with 3.40 CGPA, focus on Data Mining/Machine Learning technics, or similar degrees in the aforementioned areas
Strong analytical and problem solving skills with a proven track record of creating and implementing integrated, multidiscipline solutions. Proficient in statistics (in particular time series analysis), machine learning/data mining (clustering AND classification technics) and strong analysis skills
Chipset integrated circuit testing and high volume manufacturing experience would be an added advantage
Exceptional interpersonal communication, relationship management, effective listening and influencing skills that result in strong working partnerships across organization boundaries
Experience of full ownership and work independently on 1 full product cycle is a must

Software Development & Validation Intern Resume Examples & Samples

Create automated tests for components to enable agile development and high quality
Develop techniques to measure performance and quality from simple Windows applications
Perform white box testing on Windows systems, such as API code coverage
Write documents that explain test frameworks and test plans
Unrestricted right to work in the US without requiring sponsorship
Completed 2-3 years of a 4-year Bachelor's degree program in Electrical Engineering, Computer Engineering or Computer Science
At least 3 months of work or educational experience in C++, C#, Java, and Python and digital signal processing

Validation Solutions Developer Resume Examples & Samples

Development of functional IP models of complex CPU behaviors and system interconnect protocols
Development of validation environment infrastructures and capabilities
Development of modular validation methodologies enabling effective integration and reuse
Strong team player with solid interpersonal and communication skills
Proficiency in C/C++ and object oriented design methodologies, including algorithms and data structures
Proficiency in developing build & run-time automation solutions using scripting languages (Perl, TCL, Python)
Knowledge of S/W development practices and quality standards
Knowledge of Linux/Unix and/or Windows based S/W development environments & tools
Proficiency in SystemC and ESL modeling
Proficiency in HW design & verification methodologies including associated CAD tools & flows
Working knowledge of high-speed interconnect or memory interface protocols (e.g., PCIe, QPi, DDR)

IoT Solutions Validation Engineering Manager Resume Examples & Samples

7+ years of experience in successfully leading validation of enterprise class solutions, including hardware and software integration
3+ years of experience in setting up and managing cloud based validation infrastructure
3+ years of experience in effectively using third party outsourcing methods for results delivery
7+ years of experience in effectively managing software product life cycles from planning to validation and product delivery
5+ years of effectively managing a direct or virtual cross-site team
5+ years of experience in customer interactions is highly desired

Senior IP Validation Engineer Resume Examples & Samples

Ability to comprehend industry standards as well as internal micro-architecture specifications; strong command of assertion based pre-silicon verification methodology for SOC's; significant experience with all phases of digital logic development from concept and high-level specification to silicon to production
Knowledge of PC system architecture, CPU, Platform Controller Hub (PCH) architecture, x86 bus interfaces and SATA, USB and PCIe bus interfaces
Have a working understanding of, a Unix based design environment, typical digital design tools, test plan development, test writing/debug, tracking and resolution of design bugs
Experience in HDLs, System Verilog & OVM/UVM methodology
Familiarity in testbench, BFM and scoreboard development
Knowledgeable in OOP (Object-Oriented Programming) and scripting languages such as C/C++, Perl, Java
Knowledge in DFT functions and protocols including JTAG and scan methodologies is a plus

RTL Validation / Verification Engineer Resume Examples & Samples

Defining, implementing, and deploying verification capabilities, methodologies, and process improvements for IP verification
Development of test-plans, test-bench, BFMs, checkers, trackers, scoreboard and functional coverage
Working closely with design engineers, micro-architects, and other team members to ensure high quality of test-plans, verification environment, and tests
Working with post-silicon validation teams to resolve silicon-level sightings
Participation in system integration and verification in cooperation with development teams to conduct integration/bring-up activities on platforms

Validation / Automation Engineer Resume Examples & Samples

Test automation programming, test planning, test case creation, test execution, debugging, and defect analysis/reporting
Understanding the Microsoft PAC process requirements and being able to document as requirements for Intel
Executing the PAC validation process on-site against Intel software driver & FW packages BKC's parallel to Intel PAC validation runs by the business unit
Provide timely PAC status based on results for go/no-go software delivery decision
Working directly with Microsoft development and test teams to understand changes in PAC process and quickly adapt and document any process change
Developing and documenting the ability to execute a core set of Microsoft WHCK tests as part of BKC validation
Provide basic level triage of issues observed and manage appropriate escalation path
Candidate must possess a minimum of a Bachelor's Degree in Computer Science and 3+ years of relevant industry experience
3+ years of software dev or testing experience will be necessary, and you need to have completed at least a full application product development cycle or two in a test development or test automation role, including a thorough knowledge of the development, test, release and support processes
Strong design, programming, and debugging experience in C, C++, C#, VB.Net, or other high-level programming language is required
Need to have solid grounding in the real world of testing applications
Must also demonstrate familiarity with Intel(c) architecture
Knowledge and understanding of the Microsoft Test Automation Environment a plus
Experience with platform and/or software validation methods and supporting infrastructure including WHCK certification and Powershell components
Experience with Microsoft, the Microsoft Operating system internals and Microsoft Kernel Debugger a plus
Experience with pre-production HW devices and SoCs is highly desired
Knowledge of WHCK certification a plus
Ability to work independently / remotely, manage a technical team and drive problems to a solution within Intel or Microsoft
Must possess excellent organizational, prioritization, written/verbal communication skills, ability and flexibility to meet project deadlines, be detail-oriented, a self-starter, as well as being able to accomplish tasks in a dynamic team environment

SSD Validation Development Intern Undergrad Resume Examples & Samples

Must be pursuing a BS degree in Electrical Engineering, Computer Engineering, or Computer Science
At the BS level only, must have the unrestricted right to work in the US without requiring sponsorship
Minimum of 3 months experience with programming in a high level language and scripting
Minimum of 3 months experience with Windows and Linux operating system
Minimum of 3 months experience in web development
Validation and/or debug experience
Storage protocol experience (SAS, SATA, AHCI, and/or NVMe)

Analog Validation Engineer Intern to CG Conversion Resume Examples & Samples

BS or Masters in an Engineering degree
Minimum 3 months experience with transmission lines and signal integrity
Minimum 3 months experience in the use of lab instruments needed to conduct electrical validation
Minimum 3 months experience in computer system setup and operation
Experience with Python and Microsoft Excel

Validation Factory Program Manager Resume Examples & Samples

BS or higher degree in computer science, electrical engineering, computer engineering or related discipline + 6 years of relevant industry experience, including 3+ years of experience in program or project management, and manufacturing test experience in a high tech industry
Experience managing outsourced services
Experience managing customer issues getting them into successful resolution
Experience with Post-Si validation including test plan, test content & tools, functional validation, etc
Familiarity with validation platforms and SW stack including operating systems, drivers, BIOS and FW
Demonstrated ability to plan and manage validation project execution, from requirements to validation and subsequent delivery and support to customers
Strong discipline and attention to detail in ensuring effective high quality validation that minimizes bug escapes
Demonstrated ability to listen, understand, and respond to customer questions/issues
Ability to grow skill set and working methodologies
Good written and verbal communication skills. English and Spanish communication

Power & Thermal Validation Engineer Resume Examples & Samples

Enable power and thermal management features & flows
Run pre-Si power management simulation
Work closely with silicon design and architecture teams on power validation and correlation
Characterize the product's behavior vs. different thermal and power constrains
Hands-on experience of 1-2 years in validation
Details oriented

SOC Platform Validation Technologist Resume Examples & Samples

Thorough knowledge in SOC architecture and HW/SW integration and FW/SW testing
Experience in Window/Android OS bring up and Window/Android internals and debugging
Experience in subsystem FW/SW bring up (connectivity, media, graphics, security etc)
Hand on experience in Python or Perl , C++ or C
Hand on experience in PreSilicon platform (FPGA or emulation)

Core Architecture Validation CG Resume Examples & Samples

Experience in integrated circuit logical validation concepts and methodologies
Familiarity with CPU architecture/assembly
Experience in working with Verilog* and Specman*

System Validation Lab Student Resume Examples & Samples

Student in an academic institution of high education, studying for B.Sc. in Electrical or Electronic engineering
Ability to work at least 4 days a week
At least a 1.5 years till graduation
Good communication skills, and good team work
Good English
Experienced with lab work and board final checks (BADAS), and debug- advantage

Senior Analog Validation Engineer Resume Examples & Samples

Be responsible for system level Electrical Validation (EV) of analog circuits and channels (High speed IO, Voltage regulators and related circuits)
Characterize and validate internal analog circuits, analyze measurements and develop test methodologies
Ensure products conform to standards and specifications (product and system level)
Develop plans and cost estimates and assess projects to analyze risk while applying statistical approach
Develop procedures, analyses and design for computer components, products, and systems
Initiate, guide, and coordinate implementation in customer’s systems
You should possess a relevant educational qualification: a Master or a Bachelor of Science degree in Electrical Engineering is required
4-5 years of relevant experience
Advantage on additional qualifications include
Knowledge of high frequency applications on electrical signals
Lab work experience in high accuracy signals measurements
Knowledge on control systems theory

Senior Validation Software Engineer Resume Examples & Samples

The candidate should have knowledge/experience of C or C++ and multi core programing
The candidate should have the ability to design and code within a complicated environment
Flash technologies in storage arrays, SCSI, Fibre Channel and SAS expertise
Defect tracking tools

SOC Post-silicon Validation Engineering Assistant Resume Examples & Samples

Must be pursuing a MS or PhD in Computer, Software, and/or Electrical Engineering
Minimum 3 months experience with computer programming
Minimum 3 months experience with hardware and software debugging
Experience with functional power measurements (Leakage, Standby, Dynamic, etc.)
Experience with Network on a Chip (NOC) and System on a Chip (SOC) concepts and drivers
Experience with processor emulation tools (preferably Lauterbach) and scripting
Experience with programming in C/C++, Perl, Python, and/or LabVIEW
Experience with high speed oscilloscopes, logic analyzers, data acquisition tools/hardware

Validation Engineer Manager Resume Examples & Samples

BS/MS engineering degree with at least 10 years of relevant industry experience
Good understanding of the entire Product Development flow from conceptualization to volume production
Demonstrate a strong ability to recruit, motivate and manage highly talented engineers in delivering a product with quality
Knowledgeable of or experience in Memory Controller design and Non-Volatile memory (NVM) is highly desirable

Regional Head of Fx & Otc Trade Validation & Control Resume Examples & Samples

Directly liaison with the global business Heads and their key support partners in Sales, Trading and Structuring
Interact with auditors and regulators where required
Interact with Senior stakeholders in other support functions including General Counsel, Compliance, Tax, Operational Risk, PC & Reg Reform
Understand and influence cost and operational efficiency improvements
Represent department at key cross-functional forums such as Process Governance Committees and Project Steering Committees/ working Groups for key change initiatives
FX & OTC Product knowledge and advantage, but not essential

Test / Validation Senior Engineer Resume Examples & Samples

Working with multiple development teams to clarify testing requirements
Performing lab tests for software quality assurance for various components in the Telematics system
Analyzing test data
Communicate results and making recommendations to team members, and business partners
Identifying and troubleshooting software issues
Validating and implementing product solutions
Documenting findings in technical reports
Bachelor degree in an accredited Engineering or Computer Science curriculum
3 years engineering experience (test, design, or analysis) with software, controls, or network infrastructure
Previous software testing experience (including test case authoring, test execution, troubleshooting, and defect management)
Willing to put in extra effort to meet project deliverables
Experience with Hardware in the Loop (HIL) testing (preferably using dSPACE) and relevant tools like CANalyzer and CANape
Experience with offboard/backoffice software development and testing
Experience with software development life cycle
Experience with programming using Python,
Experience with testing automation development
Experience with Caterpillar applications (Power Systems, Constructions, Mining)
Experience with Agile software development methods

P Memory Validation Engineer Resume Examples & Samples

BS in Electrical or Computer Engineering (co-op or internship experience preferred)
Demonstrated ability to implement microprocessor systems (hardware and software/assembly)
Familiarity with memory specifications preferred
Programming experience (C++, Java, Perl, Python, Ruby), Python preferred
Demonstrated ability with oscilloscopes, logic analyzers and/or protocol analyzers

Req Ah Engineer, Validation Resume Examples & Samples

Plan, schedule and coordinate validation group activities to meet program or project targets from program concept through production
Lead the creation and manage updates to program and project ADVP&Rs
Attend customer liaison engineering meetings (as required) to provide validation expertise concerning concept designs and product development
Write test requests, monitor tests, collect results, and communicate engineering proposals for resolution of any test deficiencies
Manage contract relationship with validation service providers and tier two supporters
Review test set-up, sponsor test start sign off process and observe and monitor test execution
Provide program team & functional management with regular detailed validation progress updates
Liaise with subject matter experts to ensure validation plan meets requirements
Initiate, recommend or provide issue resolutions through designated channels
Identify concerns and initiate corrective actions (through verification) relating to product, process, and quality systems
Provide validation costs for new programs, or projects, including fixtures, material, tools, and necessary resources
Manage test properties before, during and posttest execution including test bucks, fixtures, and tested products
Obtain and manage ADVP&R signatures for internal and customer approvals, updates , and final sign off
Collaborate with global validation engineering, quality, program management and manufacturing engineering to assess and identify process or product improvements
Provide assessment and validation method feedback on advanced engineering concept designs
Coordinate validation engineering documentation per program and across programs to optimize access of information for robust designs across the enterprise
Initiate preventative and continuous improvement actions relating to product, process, and quality systems
Lead or participate in engineering disciplines such as QFD, DFMEA, DFM, and ADVP&R
Supervise the planning, execution and documentation of program and project validation
Validate components and systems according to the program and best practice requirements as defined by the ADVP&R
Participate in design reviews and cross-functional engineering meetings for current project and future programs
Supervise test set up, test fixture fabrication, and posttest breakdown
Maintain core technical competencies for validation through applied education and training
Pursue methods or process improvements, as identified, in support of company cost-savings goals and objectives
Manage the validation costs according to program or project targets
Follow the corporate policies of Magna Car Top Systems
5 years minimum experience in automotive, heavy equipment, or aeronautical fabrication industry
Associates degree preferred
Experience in machining components is required
Convertible top system component experience is preferred
Excellent verbal and written communication skills are required
Training in GD&T required
Must have been previously certified for Hi Low operation
Must have been previously certified for Lock Out Tag Out
Must have been previously certified for heavy equipment operation, certification for saws, mills, lathes, etc
Must be able to MIG and TIG weld ferrous and nonferrous materials
Capability in MS Power Point, Excel, Word, Project, and Outlook preferred
Applied training in Advanced Product Quality Planning (APQP) is preferred

Svp, Audit Issue Validation Resume Examples & Samples

Delivery of highest quality services in accordance with the Department’s policies and procedures
Establish and maintain ongoing relationships with the global GECC Audit leadership team and staff
Ability to understand regulatory, Board and Stakeholder requirements and work well with others to successfully implement them
Minimum of 8 years of relevant experience in conjunction with Bachelor's degree; or minimum of 12 years' relevant experience in conjunction with High School/GED
Strong leadership skills and strategic ability to influence others to achieve business goals and objectives
Possess strong project management skills, ability to make sound decisions, initiative and intuitive thinking
Strong understanding of industry leading practices around auditing and financial services and ability to apply them within the GE Capital organization
Experience in financial services and working directly with regulators such as the Federal Reserve, OCC, and FDIC
Proven track record of delivery of internal audit improvement programs

Associate Engineer Test / Validation Resume Examples & Samples

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Conduct failure analysis of engine components returned from field as well as test cell
Support Global purchasing in development of supplier process through effective process and part validation
Work with suppliers in developing and improving metallurgical processes
Monitor supplier Quality through periodic process assessment and component audits
Support operations through receiving inspection, line audit and final inspection
Effective communication with customers and suppliers
Effectively interact with AMT groups
Liaising with external testing laboratories for testing of bought out components and product fluids/process fluids
Graduate / Post Graduate in Metallurgy or Material Science
4 to 7 years of industrial experience in Engineering Industry preferably in the field of testing and qualification of Diesel Engine Components
Ability to communicate effectively * Knowledge of Heat treat, steel making and Casting processes
Working knowledge on Diesel Engine systems
Experience in handling metallurgical test equipments viz Hardness Tester, Metallurgical Microscope, tensile tester, Image Analyzer and other metallographic equipments
Familiar with various international standards like ASTM / SAE/ISO/JIS

Req Bat Engineer, Validation Resume Examples & Samples

Manage Design Validation (DV) and Product Validation (PV) of energy storage components and systems for multiple customers
Create Validation Test Plans including Development/Validation Plan and Report Form (DVP&R) utilizing Customer requirements and testing schedules, Validation Cross Reference Index, USCAR, UN and other industry standards
Create cost and timing for all in-house and outsourced testing
Perform quoting activities and interact with external test facilities for the execution of outsourced validation testing
Assist other engineering departments in developing test requirements to properly verify electrical and/or mechanical changes to current products along with providing cost and timing
Analyze failures and request corrective action
Deliver results in technical reports and presentations
Support multiple programs in various stages of their product development
BS in Engineering or related field, MS desired
5+ years of experience in an automotive and/or energy storage system testing environment
Energy Storage technology experience desired, knowledge required
3+ years of experience in Validation Testing
Excellent communication, interpersonal, organizational and technical skills
Self-motivation, tenacity, and determination are very useful in this position

Wealth Management Operational Risk VP-control Assessment & Validation Resume Examples & Samples

Must have demonstrated the ability to marshal the cross organizational resources to effectively and efficiently respond to deliverables
Must have effective communication skills including strong Microsoft Office skills
Exposure to Operations, Technology, Legal, Compliance and Risk functions a plus

Clearance Validation Administrator Resume Examples & Samples

Gather time period and barter information from television stations and cable networks in preparation of the launch of First Run and Off-Network television programs and keep these schedules up to date for the remainder of the season
Work closely with station program directors to secure the best possible make goods for pre-emption’s. Also, produce and distribute a weekly pre-emption report that indicates all syndicated programs and stations pre-empting and/or making good WB barter and the causes of such preemptions
Assist the Manager in keeping track of a list of National Events that affect regular programming such as national sporting events, telethons, and specials. Prepare and send mass notifications to stations requesting make goods for such events prior to their airing
Contact stations televising Warner Bros. syndicated programs outside of their contractual agreement to try and rectify discrepancies and work closely with WBDTV Contracts and Sales executives to resolve any pending time period discrepancies
Anticipate upcoming events which may pre-empt our shows (i.e. spots, telethons, specials, etc.) and coordinate with stations to move our programs and/or spots to the best available time slots
Oversees the gathering of dates and times for Ad-Hoc Movies on a monthly basis plus generate contractual discrepancy reports for such Movies and distribute these to Sales for assistance in resolving discrepancies
Assist Manager in the supervision of Clearance Validation Coordinators

Software Manager Silicon Validation Resume Examples & Samples

At least 8+ years of experience in semiconductor companies, working in the area of HWSW interface design, development and testing
Must be familiar with project tracking, resource scheduling and resource load balancing
Will take complete ownership for the delivery of work in time and with good quality
Mobility support à 3G and LTE technologies
Network address translation to help mitigate the scarcity of global IPv4 addresses, including translation between IPv4 and IPv4, and between IPv4 and IPv6

Software Engineer Silicon Validation Resume Examples & Samples

At least 5+ years of experience in semiconductor companies, working in the area of post-silicon validation
Must be very familiar with writing HW-interfacing SW, using board support package (BSP) components of a chip
Must be proficient with GCC, GDB and other embedded development and debugging tools
Must have good understanding of processor architecture, caches and different types of memories, and networking fundamental
Must be well-versed in writing and debugging multi-threaded software
Voice and multimedia services à based on the IP Multimedia Subsystem, including a capability to transcode content for delivery tailored to the end-user device

Senior Associate Engineer Test / Validation Resume Examples & Samples

The position supports the development and validation of robust electronic and electrical components exposed to severe vibration environments. The engineer is expected to work with Caterpillar design engineers, component suppliers and the Caterpillar Electronics Vibration Team to help achieve the goal of robust, cost effective components
The primary responsibilities include
1) Degree in Mechantronics or Mechanical Engineering
2) 1-3 years experience in engine/machine dynamics, mechanical measurement instrumentation (Accelerometers, microphones, strain gauges), digital signal processing
3) Experience with Pro E and FEA software is required
4) Knowledge in acquiring data using various acquisition systems & data reduction
5) Functional knowledge of random vibration technologies
6) Good written and oral communication skills,
7) Ability to multi-task and maintain a disciplined approach to assignments
1) Knowledge of synchronous rotating system dynamics,
2) Experience with higher frequency (0 to 5kHz) mechanical dynamics,
3) Finite element experience including structural analysis and normal modes techniques
4) Experience with Matlab & Mathcad is a plus,

Server Validation & Debug Senior Engineer Resume Examples & Samples

Collaborate with cross-functional team in developing HW/SW tools to improve SoC Validation coverage & Debug timeline
4+ years of experience in Silicon & System validation and debug
Proficient in using lab equipment (Oscilloscope, Logic/Network analyzer) to validate and characterize High-speed IO buses

Customer Validation Test Coordinator Resume Examples & Samples

Minimum 5 years related experience in airport operations and/or help desk call center experience
Airline industry knowledge (reservation / airport / ticketing / check-in) a plus
Prior experience working with clients in both a virtual and direct client onsite setting
Familiar with Sabre products and interface systems (PSS and open systems is a plus) in order to assist and support airline customer planning and execution of tasks
Native Sabre and product solution experience a plus
Interact GUI familiarity a plus
Prior experience working with testing methodology a huge benefit
Working knowledge of Project Management concepts – process knowledge of building timelines

Validation Associate Resume Examples & Samples

Provide project management oversight for validation activities related to products and facilities, utilities, equipment (FUE) including cleaning, steaming and computer systems
Developing validation plans for specific system implementation projects
Execute (protocol generation, execution, and final package preparation) validation activities related to the implementation of process, cleaning, steaming and facilities, utilities, equipment (FUE) changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions
Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's
Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the company, validation techniques/approaches and systems utilized
Lead and represent Validation in multi-departmental meetings & project teams
Identifies and implements improvements to the QA Validation systems
Participation in the change control program for modifications to qualified systems
Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others
8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in commissioning & qualification, process validation, process sciences and change control
1+ years experience in a position utilizing formal project management
Organizational and management skills to coordinate multi-discipline project groups
Ability to speak, present data, and defend approaches in front of audiences and inspectors
Ability to comprehend technical information related to equipment, processes, and regulatory expectations
Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations
Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred

Director, Risk Assessment & Validation Resume Examples & Samples

Execute Risk Assessments and Validations (Self-Assessments) for Substantive Global Compliance Program Areas. Self-Assessments include planning, risk assessment, validation, mitigation, reporting, and quality assurance activities
Be the architect for a risk-based compliance monitoring & testing program, to assess implementation of effective compliance risk management practices and controls by the business in effectively managing the first line of defense
Lead the execution of the compliance monitoring strategy, methodology, framework, standards for conducting compliance monitoring projects and reporting results
Develop and maintain a Compliance Monitoring Schedule based on ongoing risk assessments and the Visa risk scoring and rating methodology
Demonstrate ability to exercise good judgment in assessing the significance and relevance of identified compliance risks and perform timely escalation to CCO
Assist the business in developing first line of defense in establishing controls to ensure regulatory compliance and implementing monitoring for assurance
Develop and manage strong working relationships with the Business Areas to facilitate on-going communications to assess changes in risk profiles and assist them with improvements in their QC/test plans
Draft reports of the results of monitoring & testing projects, which are clear, concise, and provide value to management
Communicate findings and recommendations to management, determine root causes, obtain management’s action plan for remediation in a timely manner and track findings through resolution
Maintain competency through ongoing professional development and active participation through internal and external training sources
Minimum 5 - 7 years of audit/compliance testing experience
Substantive / current knowledge of building / managing U.S. regulated banking monitoring and testing programs
Strong communication skills (written, verbal, and listening)
Solid organizational, analytical and problem-solving skills, along with attention to detail
Providing hands on supervision to team members assigned to the project and reviewing their work for sufficiency of scope, ensuring accuracy and quality work in adherence to department and professional standards
Ability to work on multiple projects at one time
Assist the Senior Director with the strategic direction and effective management of the group. Ensure that all teams within the group work as a team to meet the department goals
Sound understanding of business management principles
Develop Business Partnerships. Develop a strong working relationship with line managers responsible for the assigned lines of business. This relationship is predicated on developing continuous, proactive communication lines with management
Being viewed as a leader, management consultant and internal controls expert as part of building and maintaining ongoing business/compliance relationships with management
Must be self-managing and able to work with minimal day-to-day guidance
Must enjoy being a member of a cohesive team. Competent in using Microsoft Office
Knowledge of the Financial/Banking industry preferred

Analyst Securitized Products Trade Validation & Control Resume Examples & Samples

Fobo Break reconciliation
Unmatched and Error Queue (Monitor trade activity to ensure front to back flow of trade information)
Shelf Balance Management (Reconciling all collateral in transactions/balancing the bond position from New Issue to ensure there are no breaks)
Trace Inquiry/Troubleshooting (Resolve and trade/reporting mismatches, i.e. resolve with sales and trading)
Security/Product set-up and management
Internal Account reconciliation
Update procedures when necessary in the Hyperknowledge system
Other tasks as needed. The candidate will cross train within the team to provide support to other related disciplines as necessary
Undergraduate degree required, business concentration highly preferred
2 years experience in the financial services industry preferred, but not required
Prior knowledge of MBS/ABS (Mortgaged Backed Securities/Asset Backed Securities) products preferred but not required
A preference for a fast-paced environment within a global investment bank, with frequent interaction with clients, traders and other functional areas within and outside the firm
Excellent interpersonal and time management skills
Able to problem solve quickly and work under pressure

Validation Engineer Level Resume Examples & Samples

Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities
All validation activities are conducted in compliance with US and EU legislation; as well as company Standards and Guidelines to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget. Primary Tasks and Responsibilities
Conduct validation activities in compliance with US and EU regulations, GBSC procedures and EHS requirements
Participate in the design of systems and equipment to ensure that they comply with GMP requirements
Develop validation documentation as required (e.g. specifications, plans, protocols, procedures)
Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
Execute qualification protocols as required
Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports
Prepare reports of executed protocols for review by QA
Initiate and implement change control activities in accordance with site procedures. Track and resolve exceptions during qualification activities
Prioritize qualification activities in line with the project schedule
Co-ordinate qualification activities with engineering, construction and commissioning activities
Co-ordinate qualification document review and approval
Collate and organize qualification files for turnover to QADC
Attend identified training, required to fulfil the role of Validation Engineer
Assist in the development of training material for qualification activities
Participate in cross-functional teams as required
Deputises for the QA Validation Manager when designated as appropriate
Domestic and international travel may be required

External Validation Confirmations Analyst Resume Examples & Samples

Draft and check both vanilla and structured confirmations in line with the confirmations regulatory targets (EMIR/Dodd Frank) of drafting confirmations on trade date
Work on timely confirmations and ad-hoc projects to increase efficiency and streamline processes within the paper drafting space. Collaborating with internal peers and stakeholders to deliver paper confirmation infrastructure and process changes. Conduct testing prior to IT enhancement releases
Experience in drafting both flow and structured ISDA confirmations based on risk systems and term sheets essential
Solid OTC Equity or/either Interest Rates and Credit Derivatives product knowledge
Ability to multi-task, work to deadlines and accommodate varying levels of volume, drafting trade confirmations on trade date to comply with the EMIR and Dodd Frank regulatory requirements
Solid organizational skills with the ability to priorities work, whilst working under pressure
Good communication skills (both written and verbal)
Confident personality
Ability to develop and maintain good working relationships with a variety of stakeholders across the organization within Operations
Solid analytical and financial mind-set
Competent multitasking abilities with the ability to work to tight timeframes

External Validation OTC Confirmations Analyst Resume Examples & Samples

Drafting ISDA documentation for complex Credit and Interest Rate Derivative products as well as Industry and Credit Suisse change initiatives
Drafting bespoke confirmations using the 2002 and 2006 ISDA definitions for Fixed Income products,
Resolve internal and external documentation queries by liaising effectively with the Front Office, Middle Office, Legal and Product Control areas
Work and partner with Credit Suisse vendor in Pune to streamline drafting processes. Identify and implement process changes to increase efficiency and capacity saves
Work on timely confirmations and ad-hoc projects to increase efficiency and streamline processes within the paper drafting space

External Validation OTC Confirmations Analyst Resume Examples & Samples

Exposure to OTC Equity vanilla and structured products with possible exposure to other asset classes including Interest Rates and Credit. Drafting bespoke confirmations using the 2002 ISDA definitions for Equity Derivatives products, which include but not limited to Options, Variance Swaps, Total Return Swaps, Dispersions, Structured Equity Derivatives Options and Awaps
Work on timely confirmations and ad-hoc projects to increase efficiency and streamline processes within the paper drafting space. Collaborating with internal peers and stakeholders to deliver paper confirmation infrastructure and process changes
Good communication skills (both written and verbal).Confident personality

Risk Process Validation Associate Resume Examples & Samples

Four to eight years of financial services experience
Strong technical understanding of the financial services regulatory environment, with a focus on Basel principles and Operational Risk practices
Strong risk, process and control validation and/or assessment skills -a prior role within consulting or internal audit is desirable
Strong communication, analytic, risk management, and program management skills

Credit Risk Validation Leader Resume Examples & Samples

Acts as the CCRO delegate to the Strategies Working Group/Sub-committee, under the Credit Subcommittee within the 1st line, with capacity to delay approval of new strategies or changes to existing strategies upon satisfaction of risk related conditions; or recommend escalation to parent committee for decision
Perform independent quantitative and qualitative assessments of all aspects of the strategies including review of documentation, business cases, decision trees/ design, implementation, reliability and appropriateness
Supports the delivery of the Credit Risk Conformance Testing Annual Plan by providing testing assistance to Strategy related scope and identify key control weaknesses for remediation
Manage team of 3-4 independent reviewers, in all aspects of Strategies validation work, personnel development and personal goals
Co-manage key stakeholder relationships with the SVP, Head of Fraud Strategy, SVP, Acquisitions Strategy and SVP, Head of Account Management Strategy and their teams
Manage periodic engagement with the Model Validation team to support efficiencies and best practices
Support regulatory examinations and internal audits of the credit strategies and the credit risk validation process
Bachelor's degree in Risk related field (Business, Economics, Finance, Math/Stat, Operations Research, etc. with Quantitative underpinning) and 6+ years of relevant Risk, Credit Audit or Model Validation experience; OR Graduate degree in Risk related field and 3+ years of experience developing or managing advance risk analytics. Or, in lieu of a degree, 10+ years of relevant Risk, Credit Audit or Model Validation experience
At least 5+ years of people management experience within financial services or consulting
2+ years’ experience modeling or creating tools for underwriting, risk, actuarial, or statistical reporting with SAS (or equivalent)
Masters in quantitative discipline or MBA preferred or certification (FRM, CFA, CPA, etc.)
Experience / knowledge of credit cards / consumer finance credit lending lifecycle and business models
Strong understanding of quantitative techniques and tools supporting credit related decision making
Experience in project management or risk analytics
Ability to travel within the US for 10-15% of time or as needed

Test / Validation Senior Engineer Resume Examples & Samples

Represent the company externally
Minimum of 5 years On Highway Truck development experience
Experience in On Highway Truck Validation and testing

Senior Engine Performance Validation Engineer Resume Examples & Samples

Previous experience of conducting Risk Assessments
Validation Planning
Ability to work remotely with internal, field follow teams and customers around the world to draw consensus on path forward
Ability to review (limited) data and draw conclusions and give direction in a timely manner
Multi-task and effectively prioritise numerous simultaneous projects
Ability to work and respond quickly under pressure

Test / Validation Senior Engineer Resume Examples & Samples

Contribute to the identification, analysis, and resolution of needs and problems in a discipline for which you are beginning to build a reputation as an expert
Perform complex analysis work; identifies and solves problems
Organize and facilitate FMEAs
Assist in the creation of validation plans
Coordinate execution of product tests
Document test conclusions with traceability
Track product development issues to completion
Generate and present accurate reports for validation thoroughness, status, and results
Innovate for efficiency
Communicate technical information to team members and other business units
Support and advise other engineers, team leads, managers, internal customers, and suppliers
Accredited Bachelor's degree in Engineering plus 8 to 11 years’ experience or a Master’s degree in Engineering plus 5 to 7 years’ experience
2+ years working in proving ground / product test track environment
Working background with instrumentation techniques
FMEA & reliability terminology and techniques
Proven proficiency in Excel, Powerpoint
Ability to perform complex assignments independently
Ability to communicate technical information effectively with team members and others in work group, as well as employees in other business units
Work experience with Powertrain electronic control systems
Mathworks competency
Experience with Caterpillar corporate FMEA, Readiness, reliability/warranty tools

Embedded Validation Engineer Resume Examples & Samples

Associates Degree on Electrical and Electronics Technology
Minimum 5 years of work experience as Electronics Testing and Validation role
Experienced with various electro/mechanical equipment and hand tools
Experienced with use of multi-meters, oscilloscopes and programmable devices and other standard electronic test equipment
Experienced in making and troubleshooting Electrical wiring harnesses and test fixtures
Ability to read, understand and debug through electrical schematics and mechanical drawings
Ability to prepare written reports and make recommendations for procedural changes
Ability to install & use computer software
Ability to use Word & Excel and file management
“Hands-on” attitude
Proficient in the use of OEM and development software such as Flash Test Client, Rational Visual Test, Functional Automated System Tester, D-space, and Trace32 debugger
Experience in embedded C development is a plus

Senior Manager, Credit Risk System Validation Resume Examples & Samples

Perform ongoing Wholesale and Retail credit risk systems and parameters validation and provide insightful analysis of validation results
Investigate and evaluate data filtering and data quality relating to credit risk system validation
Develop and enhance approaches tailored to timelines and data availability, utilizing detailed or 80/20 solutions, and quantitative and/or qualitative approaches, as appropriate
Ensure Validation Policy and Framework are up to date and reflect leading edge industry practices
Review and document compliance with the minimum requirements for the Basel AIRB approach and model policy
Complete ad hoc analytical or empirical projects

Control Software Verification & Validation Process Lead Engineer Resume Examples & Samples

Developing test bench requirements to support new projects in conjunction with process partners and project lead engineers
Working with external suppliers to specify test benches
Arranging for procurement of test benches, including capital expenditure details and management of external contractors
Configuring and commissioning of new test benches, including integration of Engine Control Unit and load units
Developing an plan for the team to evolve capability, exploit new technology and support existing and future projects
Liaise with corporate HiL user groups to ensure plans are appropriately aligned with the corporate direction for this technology
Keep up to date with industry developments and ensure best practice is used
Provide plant models of machine and engine systems to support closed loop simulation testing of embedded code

Test / Validation Senior Engineer Resume Examples & Samples

Minimum of 2 years engineering experience
Strong analytical and problem solving skills along with good oral and written communication skills
Must be a good team player and have the desire to work in field/shop/lab environments
Work experience in field/shop/lab environments
Must be willing to travel up to 20% of the time
Experience in the design or development of powershift transmissions
Data acquisition experience
Lab or machine simulation experience
DATK and/or ATI Vision software experience
Understanding of controls system theory

Engineering Team Lead-test / Validation Resume Examples & Samples

Lead truck validation and testing to meet regulatory, reliability and durability targets
Experience in On Highway Truck test and validation
Bachelor’s degree in an accredited Engineering, Computer Science, or Materials Science curriculum
Minimum of 10 years experience in truck engineering or development
Understanding of HD Vocational Truck applications and configurations

Cash Equity Trade Validation & Control Resume Examples & Samples

Act as Client Service representative covering multiple clients, products and markets
Foster and maintain mutually beneficial client relationships
Reconciliations, Fails management escalation and investigation
Participation in projects and new business initiatives
Pro-active / positive attitude
Control mindset
Solid team player
Analytical problem solver

Validation Debug Senior Product Development Engineer Resume Examples & Samples

Pre-silicon development
Strong communication skills including data analysis & presentation
Programming skills in Java, Perl, C++, SQL and/or Python, including scripting capabilities for data processing
Proficiency in a Unix environment
Understanding of silicon device physics (i.e. transistor level operation) and manufacturing technology, necessary to analyze performance and electrical characterization data across different process corners
LI-SM1

Validation Automation Architect Resume Examples & Samples

The role involves working closely with Validation Management customers to define project requirements, scope and deliverables
Develop full scale project plans, schedule project timelines, and estimate costs and effort required
Track project deliverables, monitor progress and KPIs and report progress to Customers and senior management. Communicate continually with our Validation Management, Operations and Execution, Design and Engineering, and System Engineering and Estate Management teams as to status of and potential risks to projects and key deliverables
Capture notes and minutes of all meetings and distribute to teams responsible for delivery
Provide our customers and suppliers with support including but not limited to project prioritization and escalation, change control activities, and outage awareness
Building and maintaining excellent relationships across Validation Management, Operations and Execution, Design and Engineering, and System Engineering and Estate Management
Ensure all issues are escalated/documented according to Citigroup Information Technology Management Policies
Work effectively and efficiently in a highly matrixes organization
The ability to prioritize conflicting demands is an important part of the job
8 to 10 years of demonstrated Project management competency in a technology organization
Individual should possess strong inter-personal and influencing skills. Key success elements are
Active partnering skills with Validation Management, Operations and Execution, Design and Engineering, and System Engineering and Estate Management in a matrix organization
Ability to influence people and work across multiple areas of the Software Development Lifecycle (Analysts, Developers, Testing and QA, UAT and Production)
Strong experience in requirement gathering
Ability to interact with senior business and technology managers
Strong attention to detail, willingness to "roll up sleeves"
BA/BS preferably in business, finance or computer science
Knowledge of Project Management Institute (PMI) project management processes
Significant hands-on experience with Microsoft Office tools
Knowledge of key performance indicators and reporting metrics

Automation Validation Engineer Resume Examples & Samples

Develop pFMEA documentation to support processes as part of Validation process
Participate in the design of systems and equipment to ensure that they comply with GMP requirements
Compile Technical content from Team Members' for Validation protocols & reports
Develop validation documentation as required (e.g. URS, Val Plan, FAT, SAT, IQ, OQ, PQ, procedures)
Ensure the timely approval of protocols & reports
Track progress of all documentation deliverables from both Automation supplier and our client
Liaise with and direct Automation supplier submission of supplier validation documentation (e.g. FDS's, FRS, SRS's.)
Manage the Validation activities with Engineers to ensure alignment with documentation
Execute qualification protocols as required
Liaise with Regulatory for potential market implications and generation documentation as needed for submission
Initiate and implement change control activities in accordance with site procedures
Track and resolve exceptions during qualification activities
Prioritize qualification activities in line with the project schedule
Participate in cross-functional teams as required
Liaise with Operation and Process Engineering to align with process metrics required as deliverables to the Automation Project
Report out on VS process Metrics
Domestic and international travel may be required

Validation & Procurement Analyst Resume Examples & Samples

To order new hardware/software required and facilitates the smooth migration from engagement, procurement to hand over to Delivery and Build teams
Deliver changes to the infrastructure in support of client requirements
Ensure correct engagement process is followed and validation of requests is accurate
Contribute to the development and implementation of policies and standards
Interfacing with internal stakeholders, engaging with 3rd party suppliers, participation in service meetings
Undertaking work outside of direct responsibility when required, including some/all of the following
Managing the end-to-end hardware certification process
Identification, implementation, development and automation of new processes that operations are and will be responsible for
Educated to degree level or equivalent experience, with proven ability to work within a Project-related IT function
Basic knowledge of x86 platform
Working knowledge of ITIL is preferred
Ability to work with MS Excel, Word, PowerPoint, Sharepoint
Ability to work with and maintain big amount of data
Strong verbal and written communication skills, ability to communicate clearly over the phone and in meetings / conference calls
Training in communication techniques and handling of challenging interpersonal situations

Enterprise Post-silicon Validation & Debug Engineer Resume Examples & Samples

Develop post-silicon validation infrastructure (Software, Hardware, Automation, and lab setup)
Mentor and lead more junior engineers on the team
Strong understanding of modern Micro-Processor architecture (x86, ARM) and modern platform architecture
Good knowledge of RAS (Reliability, Availability, and Serviceability) features at SoC as well at Platform level
Strong knowledge of modern OS kernel (MS, Linux) and programming / scripting language (C/C++, Python, Perl, …)
Familiarity with pre-silicon environments (Verification, Emulation, Virtual Bring-Up) is a plus

Risk Process Validation Resume Examples & Samples

6 to 10 years of financial services experience
Strong technical understanding of the financial services regulatory environment, with a focus on Basel principles and specifically Operational Risk practices
Strong risk, process and control validation and/or assessment skills -a prior role within consulting or internal audit covering risk processes is desirable

100

Enterprise Silicon Validation & Debug Engineer Resume Examples & Samples

Develop pre-silicon readiness and post-silicon plan to validate specific IPs/functional blocks within the SOC (covering both functional operation and electrical characteristics)
Identify then root-cause failures found in SoC Validation and Characterization
Work with cross-functional teams to proactively improve post-silicon Validation test strategy, methodology and process
BS or MS degree in CE, EE, or Computer Science
Excellent debugging skills at SoC and System level
Strong understanding of industry standard IO interfaces(DDR3, DDR4, SATA3, USB3, PCIe3, XGbE)
Must be a self-starting team player with excellent communication skills who can work with minimal guidance
Must be organized and multitask well across different tasks

101

Operations.validation Lead Resume Examples & Samples

Develop/revise validation procedures/protocols as related to equipment to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices. Support and execution of IQ, OQ, PQ, and PPQ Validation
Develop validation procedures/protocols for site utilities product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices
Write validation summary reports as required
Maintains all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems. Lead cross-functional project teams to assure all validation activities are fulfilled in accordance with site validation plans/project timelines
Develop and maintain thorough knowledge of Canadian and international GMP requirements as they relate to cosmetic production. Acts as an expert resource for the organization on regulatory requirements/trends as they relate to validation activities
Evaluate proposed changes to validated systems/processes to ensure changes are managed in accordance with current corporate and regulatory requirements
Support quality compliance leads in any visits, audits or contacts with regulatory agencies
Work with other sites to ensure that good practices are shared and reapplied, consult with other QA organizations to share and reapply good practices

102

Principal Process Validation Engineer Resume Examples & Samples

Support/lead process validation related activities for the design, qualification and continued process verification of Shire’s manufacturing processes, including identification of opportunities for improvement and consideration of long-range strategic goals and objectives
Support/lead technology transfer related activities for external manufacturing to partners and/or CMOs
Interface with other departments (e.g., Engineering, Facilities, Manufacturing, Regulatory Affairs, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to achieve Shire/MS&T objectives relating to process validation, technology transfer and other related activities
Contribute to the development of process validation and technology transfer strategies, and manage related studies supporting validation and transfer activities
Contribute to the development of process validation master plans including those for process characterization (process design), as well as process qualification and verification, and support the execution of the plans
Review proposed changes to validated processes and identify requirements necessary to maintain validated status
Approximately 25+% travel (possibility of up to 2+ weeks duration at one time), both domestic and international
Require bachelor’s degree in a technical discipline with a minimum of 10 years relevant experience in the biopharmaceutical industry
Experience leading complex and challenging projects
Working knowledge and understanding of global (US, EU, Japan, ICH) cGMP requirements and expectations as they pertain to validation and manufacturing
Technical consultant for the department on matters of moderate complexity
Able to multi-task and prioritize with minimal management guidance
Excellent organization skills and attention to detail
Strong team member with demonstrated ability to work collaboratively with others

103

Test / Validation Senior Engineer Resume Examples & Samples

Perform complex analysis work, identifies, and solves problems
Technical delivery
Bachelor degree in an accredited Engineering program plus minimum 5 years experience
3-5 years experience in a role responsible for testing or validating Construction/Agricultural equipment, Commercial vehicles, Automotive vehicles or the related systems/components
Noise and/or Vibration testing and analysis experience; OR experience testing structural and/or powertrain systems such as axles, frames, suspensions, steering, engines or transmissions
Experience with or working knowledge of standard vehicle/laboratory test data measurement tools, such as accelerometers, strain gauges, data loggers, calipers, etc
Proficient with MS Office Software including Word, Power Point and Excel

104

Risk Process & Data Validation Resume Examples & Samples

Bachelor degree or equivalent, ideally in Finance, Economics or similar
Prior experience within Market and/or Credit Risk, preferably within process validation or internal audit
Technical understanding of the financial services regulatory environment, with a focus on Basel principles and Risk Management

105

Senior Validation Engineer, Automation Resume Examples & Samples

Experience in executing and reviewing control system validation studies
Ability to lead complex validation projects and cross-functional teams
Knowledge of global cGMP requirements and expectations (US, EU, Japan, ICH, PIC/S, WHO) as they pertain to validation
A desire and skill to work as a team member and to work with others to ensure coordinated goals are achieved
Exemplifies trust and openness and a willingness to partner with others
Willingness to receive and listen to feedback
Strong written and verbal communication skills are required. Ability to present validation strategy to cross-functional teams is required. Comfortable speaking in large groups and presenting validation data in large groups
Ability to work in a fast paced environment and ability to manage multiple projects and priorities

106

Analyst, Rates Validation Resume Examples & Samples

Tertiary qualifications in Finance or a related discipline, and may have commenced CFA studies
Understanding of the pricing of Financial markets and products
Strong communication skills with ability to liaise with a range of stakeholders with confidence
Able to diligently and accurately deliver to a daily cycle
Able to work flexibly and handle competing deadlines under pressure
Advanced Excel skills, including potentially VBA
Some understanding of market data systems and information providers

107

Validation Engineer Dublin Resume Examples & Samples

A degree in an engineering or life-science related discipline
Minimum of 4 years' experience in a Quality environment in the Pharmaceutical Industry is ideal
Proven track record with cleaning and process validation projects
A self-starter, possessing exceptional interpersonal, team work and communication skills
Proven track record in the delivery of goals and improvements
Experienced professional with the ability to work to tight deadlines

108

Mria Validation Senior Manager SVP Resume Examples & Samples

Implement and execute MRIAs and CAP validation control for GFB leveraging globally implemented best practices
Monitor MRIAs Corrective Action Plans are registered into Citi Global Systems and validate they are assigned to the right Business Owner or Champion
Actively monitor MRIAs communication forums and committees
Responsible to periodically inform and update OGC Management about emerging risk and issues related to MRIAs and overall status
Assist with the designing of programs and control enhancement strategies that drive strengthening of controls in all GFB
Implement a comprehensive process to proactively track, monitor, validate and report CAPs associated to MRIAs to ensure effective management and timely escalation (deviations, past due, change in owners, etc.)
Develop MRIA validation methodologies leveraging Citi Global best practices implemented by other assessment entities (e.g. IA)
Post-Graduate with 8+ years of experience in related functions
Relevant Compliance or Control knowledge is required

109

VP, Risk Process Validation Resume Examples & Samples

Support execution of governance, risk assessment, process review and validation, monitoring and reporting and technology strategy
Interface with key/senior stakeholders, governing bodies and business partners to discuss the status of the validation work, results of test work, and quarterly reporting
Day to day oversight and management of the Credit and Market Risk Validation book of work, including the potential to manage a small team
Six to 10 years of financial services experience
Strong technical understanding of the financial services regulatory environment, with a focus on Basel principles and specifically Credit and Market Risk practices

110

EU Validation Engineer Resume Examples & Samples

Working with the cross functional teams in the development and execution of validation activities associated with new equipment / product or system upgrades
Developing Validation Documentation (e.g. specifications, plans, protocols, procedures) to support cold chain / controlled temperature transportation and new process/product introductions to support supply continuity and process improvement requirements
Providing technical input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project
Review and approval of documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
Responsible for Commissioning and Qualification documentation generation, review and approval, where appropriate including: Validation Project Plans, FMEAs/Risk Assessments, Functional Design Specification, Factory Acceptance testing, Site Acceptance Testing, IQ, OQ and PQ protocols and reports, Investigations, Commissioning Test Plans, and User Requirement Specifications as applicable
Resolving and assisting in the closure of deviations initiated during qualification execution
Implementation and co-ordination of the change control process, review change controls for validation impact, promotes timely approval of all supporting documentation
Generation of SOP’s / other documentation as applicable
Co-ordinate qualification activities with contractors and vendors as required
Attend external training courses as required to fulfil the role of Validation Engineer
Domestic and international travel may be required (15%)

111

MIS Data Validation Analysts Resume Examples & Samples

The successful candidate will be responsible for developing, analyzing and executing data validation activities for Credit Bureau Reporting and Credit Bureau Disputes
Create and ensure detailed procedures for credit bureau reporting and credit bureau dispute process are up to date
Perform file extraction, MIS development, reconciliation, and analysis in support of Credit Bureau Utility
Perform data extraction as necessary in support of internal audit, regulatory reviews, quality control, and DQRs
Produce reporting related to Credit Bureau Disputes
Strong analytical skills in conducting sophisticated analysis using bureau/vendor data, customer performance data and marketing data to solve business problems
Banking industry experience especially in an analytics or policy role is preferred

112

MIS Data Validation Analysts Resume Examples & Samples

Perform file extraction, analysis, and reconciliation in support of accurate credit bureau reporting and credit bureau disputes
Provide direction to offshore resources supporting the MIS creation for credit bureau reporting and credit bureau disputes
Work with CRAs to develop common criteria for reject and dispute categories
Deliver data necessary to support the credit bureau utility team’s MIS
7+ years of relevant experience

113

Basel Validation Resume Examples & Samples

Overseeing key components of the Validation Framework. Reviews include the following products: derivatives, loans, securitizations, and other debt and equity. Report coverage includes the FFIEC 101 (Basel III Advanced Approach); FR Y-9C, FFIEC 041 (Basel III Standardized Approach), DFAST, CCAR
Overseeing the Validation Test Plan and providing various governance committees with progress metrics
Cultivating relationships with senior key stakeholders across several departments
Drafting recommendations and liaising with the business units to remediate risks, findings and gaps identified during the validation process
Analyze identified issues for their impact on capital and other upstream and downstream processes or systems, as well as escalating these issues to senior management
Monitoring, tracking and reporting project progress to Senior Management
Ability to organize and present data in a meaningful way, including analyzing and summarizing detailed information from various sources
6+ years of prior experience in a line role or supporting a finance or reporting function
Strong written, communication, and presentation skills, including the ability to liaise with and influence senior subject matter experts
Strong quantitative and qualitative analytical skills
Ability to multi-task, adapt, and work well under pressure
Advanced Excel, Word, and PowerPoint skills
Sense of ownership and accountability for work
Prior audit or consulting experience
Understanding of the Basel Framework and/or regulatory reporting
Experienced with testing and proposing remediation plans

114

Associate Operational Risk Process Validation Resume Examples & Samples

Perform independent validations of select Operational Risk processes, including interpretation of Basel relevant regulations and implementation thereof
Interface with key stakeholders, governing bodies and business partners to discuss the status of the validation work, results of test work, and quarterly reporting
Strong risk, process and control validation/testing and/or assessment skills
A prior role within consulting or internal audit covering risk processes is preferable
Strong technical understanding of the financial services regulatory environment, with a focus on Basel principles as it relates to Operational risk capital requirements and practices

115

Memory Validation Engineer Resume Examples & Samples

Perform DDR4/LPDDR3/LPDDR4/LPDDR4x/GDDDR5x bring-up, timing characterization and validation on Tegra processors
Perform signal measurements and protocol checking on DRAM interface to make sure designs are meeting JEDEC Spec
Perform registger tuning on Tegra processor/DRAM memory register settings for system stability, performance and power optimization
Perform regression and interoperability testing on DDR3L/LPDDR3/LPDDR4 and all future DRAM technology with Tegra processors across process, voltage and temperatures
Support DRAM vendors in DRAM validation/certification
Debug ASIC and board issues related to logic design & signal integrity
Work closely with Application Engineering teams to resolve customer issues in time critical environment

116

Operations Trade Validation & Control Resume Examples & Samples

Order processing & allocation
Trade confirmation to external clients
Trade Cancellations & Corrections
Trade Errors accounting & reconciliation
External Broker trade bookings
Investigation & prompt response to client trade allocation queries
Investigation & response to trade breaks
FOBO and Control account reconciliations

117

Healthcare Senior Validation Engineer Resume Examples & Samples

7-10 Years of experience as a Validation Engineer in the Healthcare domain
21 CFR Part 11 experience
Knowledge of FDA regulations required to test medical products
Expertise in quality reviews
Experienced in System Performance, Unit, Functional, Regression, Integration and User Acceptance Testing

118

Healthcare Validation Engineer Resume Examples & Samples

5-7 Years of experience as a Validation Engineer in the Healthcare domain
Strong knowledge of validating products based on SaaS, cloud-based technologies
Strong belief in quality compliance and following rules
Knowledge of testing medical products

119

Commissioning & Validation Engineer Resume Examples & Samples

Assist in development of Validation Plans and development of Installation Verification, Functional Testing and Performance Qualifications (PQs) for equipment
Working with the team to ensure all aspects of activity within the commissioning and Validation of equipment adhere to required policies and procedures, including safety and training
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
Prepare and execute validation protocols and can complete risk assessments from a quality system perspective

120

Validation Mgmt Services Financial Analyst Resume Examples & Samples

Preparing and presenting monthly book of work financials to senior management
Creating and maintaining projects in our project management tool, PTS, to track financials
Coordinating internal transfers
Coordination with test managers to manage and maintain project budgets
Tracking Accruals
BA/BS preferably in Business or equivalent experience
5 + years of Financial Services IT financial administration and report building experience
Strong verbal and written communication skills, with ability to communicate at all levels within the organization
Experience with Project and Portfolio Management (PPM) practices
Significant hands-on experience with Microsoft Office tools
Microsoft Excel advanced skills interfacing, creating pivot tables, charting, and Visual Basic
Experience managing stakeholder relationship/expectations

121

HV Battery Validation Engineer Resume Examples & Samples

Become safety certified to perform high voltage electrical and mechanical tests
Develop design verification plans with efficient test timing
Manage test requests, schedules and facilities
Execute functional, safety, and thermal performance tests on battery pack systems
Coordinate and direct certification testing at external test sites
Identify and facilitate the resolution of design issues
Perform data analysis, generating comprehensive technical reports
Develop intellectual property ideas for electrified vehicle systems
Create and publish standardized test methods
Bachelor of Science degree in Electrical, Mechanical, or Chemical Engineering
3 or more months prior product validation or development testing experience
3 or more month’s automotive product development experience
Should enjoy technical, hands-on work
Strong teamwork, organization, and oral/written communication skills
Knowledge of high voltage battery systems and hybrid/electric vehicle systems
Experience working with large format Lithium Ion battery systems
Practical knowledge including test planning, instrumentation and set-up
Should have knowledge of MATLAB, LabVIEW, Microsoft Programs

122

Trade Validation Cash Securities Resume Examples & Samples

Take ownership of Trade Validation and Control functions for the Sales Trading & Dealing desk and act as the main operations contact for clients. This will give a great exposure to Front Office and external clients
Perform daily allocation and confirmation process as well as control processing such as exception management and fail management for various APAC markets
Understand internal processing flow and multiple systems thoroughly to be able to cope with daily issues
Responsible for process improvement and systems enhancement to reduce exception, cancellation and correction
Handle queries from internal and external clients for allocation, confirmation queries to settlement and ad hoc queries
Work closely with India team for offshoring functions. Be a point of contact to liaise with them as well as internal & external clients

123

Process Validation Engineer Resume Examples & Samples

Draft and Approve protocols and reports as required
Execution of IQ, Process Development, OQ and PQ on new/revised processes as required
Local use of Validation Toolkits
Publish site specific progress reports as required
Quality of completed validations [Effectiveness, schedule adherence, minimum deviations]
Create and control PFMEA and control plans throughout product life cycle
Participate as required in regular peer reviews of completed validations and advising suggested improvements in practice
Assist with Process Development, conduct DOE and MSA
Participate in regulatory audits and inspections
To link with Post Validation activities including closure of ACR and ECO (Change Control)
Support site change control procedures
Execution of software validation protocols in accordance with site validation procedures and toolkits
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation
Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps
Documents software development and/or test development by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards
Tracks software development effort by creating and maintaining records in the approved tracking management tool

124

Computer Systems Validation Project Associate Resume Examples & Samples

Ensures documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies
Review functional or technical requirement documents and develop test cases to the stated requirements including positive and negative testing
Review the accuracy and completeness of software validation deliverables created by other process teams (e.g., Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)
Create Traceability Matrices linking approved requirements to test cases in HPQC (both automated and manual)
Works with fellow validation and project team members in a dynamic environment with shuffling priorities and responsibilities
Provide expertise in the review of all deliverables across the project lifecycle, ranging from requirements documentation to final protocol reports
Keeps the validation lead informed of any issues regarding the quality of the deliverables, or any potential sources of impact to the project timeline
Accurately report the status of assigned deliverables and support other compliance work as necessary
MUST BE LOCAL TO LOCATION OR WILLING TO RELOCATE (relocation not covered)
Experience with IT Systems lifecycle (development, testing, implementation) – Quality assurance domain preferred
CSV skills (can be IT QC skills, but also could be CSV skills in the context of delivering regulated system implementations
Knowledge of software testing
Exposure to cross functional teams (lead, co-ordination)
Ability to deal with all employees and external business contacts while conveying a positive, service oriented attitude
Attention to detail, quality, time management and customer focus
Interpersonal and ability to operate effectively in a matrix environment
Ability to write, read, and understand business as well as technical requirements
Experience with MS Office applications including: Word, Excel, PowerPoint

125

Post Silicon Experienced Validation Engineer Resume Examples & Samples

3-10 years of experience in the industry, preferably chip and/or system Validation
A precise attention to details, Self-motivation, problem solving skills
People skills and team spirit

126

SV & Fpga Validation Resume Examples & Samples

Planning, Developing and Enhancing Test Content and Capabilities (in C and/or C++, Maestro, Assembly*, Python*, Perl)
Executing new and existing Tests on the IP FPGA, SOC HFPGA, Emulation models
Debugging Test Failures/sightings using a variety of Debug Tools to perform characterization of the issue and identify the failing component. This will involve hands on experience in source-level debugging, I2C, oscilloscope and/or bus analyzers
Interfacing with Architecture, Design, and Pre-Silicon Validation teams in developing, modifying and improving tests
Demonstrating excellent communication and interpersonal skills
Working on multiple parallel development and debug tasks simultaneously
Great team player, willing to learn and flexible
Familiar with DMA Architecture
Experience in firmware development
Experience in Agile and Scrum methods
Rocket & Maestro
Power Management validation background
Embedded Low level Software Experience
Familiar with RTL design and preSi validation example in using Synopsis VCS

127

System / Solution Validation Engineer Resume Examples & Samples

Creating and maintaining software test plans and designing test cases (mostly automated)
Development of validation framework and automated tests
Cloud environment configuration and automation
Software deployment on prototype hardware
Software/hardware components integration
Testing of FPGA components and the whole solution
Analyzing test results to ensure correct functionality and determining root causes of failures
Documenting test results and maintaining records for later analysis
Coordinating with internal/external stakeholders who will be affected by testing
Occasionally travelling to and assisting the customers or other Intel teams located across the globe
Improving personal skills and technical knowledge
Knowledge of technologies that are listed above or willingness to learn them
Deep knowledge of Linux installation, configuration and administration
Excellent programming and technical skills in at least 2 of the following programming languages: Python, Bash, C++, C, C#, Java
Knowledge of Object Oriented Programming is a plus
Expertise with network protocols (TCP/IP stack, network configuration etc.) will be very helpful
Knowledge of validation process and tools
Experience in performance, integration, system and solution testing of software and hardware products in a production scenario with ability to analyze and present results
Troubleshoot customer issues and interface with appropriate product teams on problem resolution
Familiarity with virtualization and cloud technology (e.g. OpenStack)
Knowledge of FPGA, VHDL, Verilog is a plus
Practical experience in data center architectures (compute, storage, networking) is a plus
Good English skills for verbal communication and technical documentation authorship
Practical knowledge of software application life cycle (with maintenance and updates)
Strong problem solving skills and good analytical skills
Business related aspects and experience on discussions with customer will be advantage
Good teamwork and cooperation
Bachelor or MSc. with 3+ years of experience in working within defined software development lifecycle
4+ years of experience with Linux systems
2+ years of programming experience
1+ years of experience in development of test cases, test tools and identifying automation opportunities

128

Dpdk Validation Engineer Intern Resume Examples & Samples

Must possess a Master Degree or bachelor Degree in Computer Engineering, Computer Science or equivalent. Additional qualifications include
Familiarity C/C++ languages, script languages such as Perl, Python, Shell is preferred
Familiarity Linux* platform. Experience in Linux* software development and debug
Familiarity Linux device driver and kernel space development are nice to have
Ability to read and understand existing C/C++ source code and scripts
Knowledge of software development and test processes
Flexible and eager to learn; work well with team members
Proficiency in written and spoken English

129

Software System Validation Engineer Resume Examples & Samples

Demonstrated knowledge of Python, TCL, and BASH or other shell scripting
Ability to review/understand programming including Python, TCL, BASH, and C/C++
Excellent software debugging/problem solving and time management skills
Knowledge of computer architecture, system network architecture, platform architecture, and validation architecture
Working knowledge of the Linux and Windows operating systems
Linux and Windows admin knowledge
Ability to work successfully in a multi-site team environment
Good knowledge of system network architecture
Omni-Path, InfiniBand, or another HPC interconnect is strongly desired
Experience working in a software development and validation environment using agile methods

130

Core Architecture Validation Student Resume Examples & Samples

Experience in development in integrated software and/or hardware environment
Experience in developing Register Transfer Level (RTL) validation environment
Experience in Emulation
Experience in Chip logical validation concepts and methodologies

131

PHY Integration & Validation Student Resume Examples & Samples

Position is open for Electrical Engineering students
Knowledge in RF and Wireless protocols- advantage
Knowledge in Linux and Android- advantage
Good problem solving skills and good communication skills

132

Hardware Validation Engineer Resume Examples & Samples

Research into test/validation technologies/methodologies
Write scripts to automate tests
Develop firmware/scripts/applications to test the hardware
Debug/tune of custom hardware
Bachelor’s degree in Electrical Engineering, Computer Science, related filed or equivalent experience
1+ years overall experience in validation/test experience
Experience with NI Test Stand, NI LabVIEW, and/or NI LabWindows/CVI
Experience with prototyping solutions and bench testing methodology Schematic capture and PCB design experience
Experience with video, cameras, audio, power supplies, I2C/SPI/UART busses, and electrical signal characterization
Strong scripting experience (i.e. shell, Perl, Python, etc.)

133

CSV Validation Engineer Resume Examples & Samples

Develop a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements
Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology
Keeps systems and processes developed for computer and automation systems validation up to date and compliant
Gives guidance on all activities related to computer and automation systems validation
Support activities include, but are not limited to, SOP creation, documentation review and approval
Including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports
Compiles and analyses validation data and makes recommendations for changes and/or improvements
May also investigate and trouble-shoot problems which occur and determine solutions
Maintains all documentation pertaining to computer systems validation
Bachelor’s degree in a technical, scientific or related field is preferred
Min 6 years of related industry experience
Min 3 years of experience in CSV system development life cycle is required
Validation experience with ERP, MES, LIMS, and Quality Systems is preferred
Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required
Strong knowledge of system development life cycle is required
Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred
Strong leadership skills and the ability to work in cross-functional team environments, as well as independently, and to manage multiple and competing projects are required
The ability to travel up to approx. 10% (domestic and international) is required

134

Validation Engineer / Janssen Fuji Resume Examples & Samples

Have more than 5 years working experience in pharma
Process excellence (6sigma), lean concepts and tools, and green belt
Have experience of automation of equipment’s and root cause analysis
Willing to learn and learning mindset for personal and professional developmentValidation

135

Director, Market Validation Resume Examples & Samples

Bachelor degree in business, marketing, management, computer science or a related field is required
A minimum of 10 years of related experience is required
Significant experience in customer relationship management, specifically in delivering software solutions to economic buyers, specifically in the digital health care space, and in a highly matrixed and fast-paced environment
Expertise in business development and commercial/operational functions of healthcare technology businesses for health systems
Understanding of and experience with bringing digital products to market in a regulated environment, specifically managing custom customer requirements
Broad understanding of healthcare systems, with an emphasis on healthcare technology
A service orientated and entrepreneurial mindset with a talent for addressing complex customer needs pragmatically and cost-effectively
Proven ability to execute complex change management programs/motivate and mobilize teams and organizations
Strong executive presence and proven ability to align and influence a broad set of diverse and senior internal and external stakeholders
Significant understanding of and experience with agile development processes
Strong project management skills and experience working within a centralized PPMO process
Leadership capabilities and negotiation skills, as well as the ability to effectively assimilate and communicate complex information from multiple sources. Ability to recognize and lead the resolution of project issues and roadblocks is an essential requirement for this position
Experience understanding customer needs, identifying trends and feeding those needs into product development to ensure highly flexible and configurable solutions that enable speed to market and control costs
Ability to partner and engage with a cross-section of people at multiple levels of the organization required. Outstanding relationship and communication skills, excellent written, verbal, and presentation skills, with the ability to convey complex technical ideas to diverse audiences
Strong leadership and communication skills are essential.Marketing

136

Validation Assistant Resume Examples & Samples

Cleaning validation for liquid products
Manufacturing and Packaging Process validation of liquid products
Packaging Process validation of solid products
Coordination and follow up of activities within the Validation/qualification department and versus the other Internal (Production, Quality Control, Quality Assurance, Logistic, Data Management, …) and External departments (R&D, …)
Implement of standards for Validation at the site according to the references from GMP, FDA and J&J
Propose the relevant protocol and ensure the appropriate approval flow (QC, QA, Production)
Ensure the execution, the coordination and the follow up (Planning, Production)
Establish the validation reports
Propose corrective and preventive actions
Implement standard for Validation at the site according to the references from GMP, FDA and J&J
Propose the relevant protocol and ensure the appropriate approval flow
Coordinate the sampling of bulks and finished products validation batches
Establish the validation reports(and update them if needed)
Check, critically, the test results and communicate any anomalies / non conformities
In case of non-conformity, participate to the investigation and propose corrective and preventive actions
Approve the recipes
He/she establishes the validation protocol taking into consideration the equipment qualification report, the info from Data Management and production
He/she provides Production with the needed info/documentation following the validation batches
He/she issues the packaging validation report and ensure the appropriate approval flow
He/she issues/updates the documentation impacted by the validation (procedures, recipes, SAP tables…)
He/she updates the Validation plan
This function handles and follows up the KPIs
He/She coordinates and updates the VMPs
He/She coordinates and distributes the information related to Validation and qualification for PQR issuing
He/She coordinates and support the Validation/Qualification/Calibration meetings
He/She coordinates the VMO (Validation Manufacturing Operations)
He/She acts as interlocutor for the Validation/Qualification activities with reference to J&J and/or external Audits/Inspection

137

IPB Control & Validation Unit Manager Resume Examples & Samples

Bachelor of Arts or equivalent experience; Masters preferred
Highly effective verbal and written communications skills
10+ years of previous banking and Internal Audit experience (AML and Operational Risk Management experience is a plus) under the US Banking Regulatory environment
Experience in regulatory examination environments required
Proven people and team management skills
Requires understanding the legal and regulatory environment of the business

138

Production Validation Associate Resume Examples & Samples

Ensure energy produced in billable periods is accurately tracked
Evaluate and adjust production data in the event of a reporting error
Work with Customer Care to help resolve issues that have resulted in billing errors
Work with Finance teams when a SolarCity customer has negatively affected production
Work with equipment vendors to correct production totals or replace defective equipment
Document all actions in SolarCity’s CRM
Drive other projects as required or as business needs change
Bachelor’s degree in Math, ComSci or related, or demonstrable mathematical prowess
Enthusiasm for green technology, in particular solar and energy conservation technologies
Ability to clearly communicate and present complicated information to less-technical audiences
Understanding of a technical support environment and processes, including ability to document case histories clearly, accurately and with detail. Experience with CRM systems, mobile case/ticketing systems, bug tracking systems
Grasps basic concepts of electricity (AC/DC, current, voltage, resistance, power vs. energy etc.)
Intermediate/Advanced skills with Microsoft Excel
Regular, reliable, predictable performance required
Must be able to successfully pass a pre-employment criminal screen. Additional pre-employment driving and drug screens may be required based on job responsibilities

139

Lead Commissioning Qualification & Validation Engineer Resume Examples & Samples

Provide Commissioning, Qualification and Validation (CQV) services to projects either independently or as part of a larger team
Generate documents such as master plans, design, installation and operational qualification protocols, equipment, facility and utility protocols, cleaning validation, computer validation, sterilization validation, data reviews, SOP development and development of final reports, whilst leading others in similar activities
Extensively interact with clients to identify CQV requirements and work towards solutions that meet schedule, cost, and quality expectations and requirements
Individual must be self-motivating, detail oriented, with superior skills in planning, organizing, and communicating CQV project tasks across a multidisciplinary team
Win work via Business Development techniques with current and new clients
Lead teams of junior and senior engineers
BS or MS in engineering, computer sciences or life sciences, or equivalent work experience
A minimum of 10 years validation experience in the biotechnology and/or pharmaceutical industries required
A thorough and working knowledge of Good Manufacturing Practice (GMP), GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems and validation of processes
Must have excellent written and verbal communication skills, experience with Microsoft Word, Excel, Project, with hands-on experience working in a corporate setting
Ability to be a productive and supportive member of a project team, as well as working independently
Preferred candidates will have demonstrated validation experience in the following areas: manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of the Validator 2000 and/or Kaye Digistrip
A thorough knowledge of good documentation practices
Must have worked on projects utilizing advanced German and English language skills, whilst French language skills would be highly beneficial

140

IP Validation Engineer Resume Examples & Samples

Good knowledge in system logic, computer architecture and PC's component and ecosystem
Some Hands-on experience using lab test equipment such as oscilloscopes, logic analyzers and software or kernel debug tools is a plus
Highly independent with pro-activeness and self-initiatives

141

Independent Issue Validation Resume Examples & Samples

Bachelor's Degree or equivalent; 7+ years of audit or bank regulatory compliance experience
Strong oral, written, interpersonal, and communication skills
Background in operational risk management, information technology security, financial services regulatory compliance and related laws and regulations, including Unfair or Deceptive or Abusive Acts or Practices (UDAAP)
Strong attention to detail and focus on accuracy
Demonstrated ability to interface effectively with various levels of management
Ability to develop and maintain close working relationships with business units
Accountable for and able to manage time effectively and work under minimal supervision both individually and as part of a team
Willingness to obtain and maintain professional designations
Ability to plan, analyze, and prioritize work effectively
PC literacy (MSWord, Excel, Access, electronic mail such as Lotus Notes or Outlook)
Ability to travel- approximately 10%

142

Program Validation & Verification Mgr Resume Examples & Samples

Establishes the direction and required progress of the assigned team(s) activities. Provides guidance on the team’s direction and extent of progress. Leads the team’s decision making, providing direction of progress and extent of progress
Ensures customer satisfaction through frequent interaction with the customer to obtain feedback on the progress of the testing and any areas of concern. Understands Technical Compliance Requirements for both customers and UTC Aerospace Systems; understands the need to plan for all compliance requirements and drives to completion
Provides technical leadership for the assigned programs test activities. Operates with a knowledge of all technical requirements. Responsible for the development of a pathway to satisfy all technical requirements within budget and schedule constraints or have ways to have a requirement changed if impossible to meet. Ability to effect necessary progress in all aspects of testing. Ability to communicate verbally, in writing and by presentations to both technical and non-technical personnel. Ability to interact with all groups interfacing with the assigned team to ensure that progress is phased effectively. Responsible to lay out engineering plans and implement them effectively. Responsible to lay out a test and validation plan in sufficient detail such that the management of the plan will provide visibility to indicate when corrective measures are needed. Makes best use of GLPDS tools. Ensures the assigned technical team has the necessary budget to complete the project on schedule
Ensures that the assigned team utilizes the allocated budget to his/her team in the most effective way
Regularly produces a status of the budget to ensure that planned work accomplished is compatible with budget expenditure
Notifies program technical manager when a significant under or overrun of the budget is anticipated
Provides Continuous Improvement leadership in developing and using standardized component engineering processes, tools and templates for new product introduction, enhancing component commonality and re-use
Demonstrates application of the UTC Aerospace Systems three circles, including the UTC Aerospace Systems People Philosophy

143

EV Tools Validation Engineer Resume Examples & Samples

Familiar with Intel x86 architecture and PC high speed IO Interface specifications such as PCIe, USB2.0/3.0, DDI, HDMI, SATA etc
Working knowledge of Microsoft Windows, Chrome and Mac operating systems
Scripting experience/knowledge to enable functional testing and basic testing automation languages such as Python, Powershell
Familiar with creation, execution and management of well-structure test plans and test cases
Familiar with software QA/testing frameworks (Selenium or similar) and bug tracking tools
Demonstrate experience in software troubleshooting/debugging skills
Familiar with Agile methods (Scrum, Extreme Programming) is a plus
Familiar with test-driven development and unit testing is a plus
Knowledge of software engineering practices, source control management, testing methodologies is a plus
Ability to successfully work in a team setting, across cultural and geographical boundaries in cross-geography teams
Positive attitude and customer service orientation
Ability to work independently towards defined goals
Ability to ensure a timely completion of deliverables and collaborate with partners and stakeholders
Tolerance of ambiguity and adaptability to change
Demonstrate experience in project and stakeholder management

144

Solution Validation Services Director Resume Examples & Samples

15+ years of experience in managing large complex technology deployments
15+ years of management experience
Experience working with global peers and cross-functional teams
Experience with managing remote teams and individuals
Experience in leading a professional services team is desirable
Knowledgeable of Advanced Services Program model deliverables and expectations
Superior presentation skills. Be able to articulate value-add to Sales teams and Customers up to C level Execs
Understanding of competitors products and offerings
Familiarity with entire portfolio of Cisco products
Experience with application and/or software development
The ability to influence effectively in cross-functional teams is a must. This includes cross-functional contribution and impact with development engineering on product development and serviceability design
Must have excellent interpersonal, written and verbal communication skills
Financial acumen. Experience with managing investments, budgets and headcount

145

Senior Engineer Post Silicon Validation Resume Examples & Samples

4-9 years of relevant experience
REQUIRED
4 to 9 years of related experience in Silicon Bring Up and Post Si Validation
Strong C / C++ programming skills
Strong scripting skills- Perl/Python
Able to analyze and debug firmware and hardware problems
Understanding of computer storage devices
Experience with FPGA, PCB, Logic Analyzer, Oscilloscope and other tests and measuring instruments
Excellent teamwork, strong written and verbal communication skills
DESIRED
Experience with Tensilica or ARM microprocessors
Experience with storage device protocols such as SATA, SAS, or PCIe

146

Senior Validation Contractor Resume Examples & Samples

Development of Validation Plans, Equipment Leveraging Strategy, Equipment grouping/bracketing strategy & SOP's
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
Be involved in required Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures
Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective
Provide expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment
Assure that all validation test procedures are in line with current technology, corporate and governmental regulations
Leading the CQV team to ensure all aspects of activity within the group adhere to required policies and procedures, including safety and training
Responsible for review of all design deliverables from the Engineer including drawings, datasheets, specifications and engineering lists
Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all systems are managed appropriately for the entire project lifecycle
Liaise with CQV Document Generation Lead in relation to generation and approval of: DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols
Liaise with Global teams and other sites within the network
Lead the teams in preparation for regulatory, internal and corporate audits and inspections
Represent Validation and for audits and any corporate events (as required)
Report out to senior management on Validation status and metrics

147

Program Validation & Verification Mgr Resume Examples & Samples

Strong application of engineering principles and theories
Strong Microsoft Office Skills
Component test and validation experience
Function effectively in a team environment
Ability to apply Lean Principles (CIF/GLPD)

148

FAA Validation Engineer / Expert Resume Examples & Samples

Bachelor of Science degree in a related Engineering discipline required
Must have a minimum of 10+ years of related engineering experience working with FAA regulated engines with knowledge and understanding in the following
FAA Orders, Engine Certification Technical Data, Test Reports, Structural Analysis Reports, Systems Analysis, Service Documents, Engine Performance & Operability, Repair and Manufacturing Processes, Advisory and other guidance materials
Experience in gas turbine engine design / development and/or Maintenance, Repair & Overhaul (MRO) industry
Ability to determine export Jurisdiction & Classification of engineering repair data
ACE Operating system knowledge

149

Sterilisation Validation Engineer Resume Examples & Samples

We are looking for a qualified person to Minimum of a Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 5 years relevant experience
You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams. You are experienced with sterilisation validation
Microbiology skills are desirable
Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions are a must. You are a good communicator and fluent in English, both in writing and speaking. Flexibility to travel <30% of time desirable

150

Production Validation Engineer Resume Examples & Samples

2, Write validation plan and test cases at validation preparation stage; 
3, Setup or upgrade test platforms according to project specific requirements; 
4, Rolling Reliability Testing
5, Participate DFMEA for R&D, PFMEA for manufacturing 
6, Execute validation test and record test results; 
7, Submit and follow defects, assist designer reproducing defects; 
8, Write validation report at end of validation

151

QC Analyst Iv-assay Validation Resume Examples & Samples

Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in life sciences or a related field, or four (4) years equivalent experience in lieu of degree
Minimum of eight (8) years of progressively responsible job related experience with a minimum of three (3) years in a pharmaceutical cGMP environment
Working knowledge of regulatory guidance’s pertaining to GMP laboratory operations
Understanding of regulatory guidance’s for method validation and the ability to assess methods of variable complexity following these guidance’s
Ability to author SOPs, qualification protocols and reports, and complex technical data summaries with minimal oversight
Ability to perform complex data analysis using statistical tools
Demonstrated strong technical writing skills
Experience in method validation and equipment qualification
Experience performing analytical investigation with focus on root cause analysis
Possess one or more skills in the following areas
Experience in method transfer activities
Analytical equipment qualification
Use of statistical software such as jmp, GraphPad, or other similar systems
Experience working in an analytical laboratory
Experience with proteins and purified DNA
Experience with novel vaccine platforms such as virus-like particles, nanoparticles, and fusion protein

152

HIL Validation Engineer Resume Examples & Samples

5+ years of Automotive embedded domain experience
Strong Experience in Model Based Development using MATLAB, Simulink
Strong Experience in dSPACE HIL simulators, Hardware In Loop testing
Experience in Test Procedures and Test scripts development
Good Knowledge on automotive communication protocols such as CAN, LIN
Experience in CANoe, CANAalyzer and Control Desk
Experience in Dynamic Testing and ADAS features like Blind spot, Cruise control etc
Strong Experience in CarSim / CarMaker / ModelDesk / MotionDesk
Strong skills in Debugging Issues and Root Cause Analysis
Bachelor’s or Master’s degree in Engineering or Science with 6-9 years of experience
Good Knowledge in embedded programming using Embedded C
Knowledge on scripting languages - m-script, Python, CAPL
Good knowledge on Body and Chassis functions of electronic modules
Self-managing and require minimum supervision

153

Validation Test Manager With Clinical Trials Experience Resume Examples & Samples

Experience in executing software testing for Clinical Trials systems
Strong validation experience, working knowledge of GxP processes, 21CFR Part 11
Lead testing activities for the program assigned
Bottom line responsibility for testing being done on the program
Manage Stakeholder Communication
Ensure testing/validation strategy and approach is in-line with overall project goals
Ensure all testing deliverables are produced On-Time, On-Budget with Good quality
Report testing progress, blockers, get issue resolution
Review testing deliverables
Co-ordinate for client review and approval of all testing deliverables
Required to liaise with different teams within program to ensure successful delivery of testing
Ensure compliance of clients SDLC process at all times
Coordinate with testing team members onshore and offshore to ensure successful delivery of testing activities

154

Validation Test Lead With Sharepoint & Edbms Resume Examples & Samples

10 years of Experience in Life Sciences, Computer System Validation and Testing
Must possess hands-on experience in Trackwise, Sharepoint, EDBMS
Good understanding of FDA regulations, 21 CFR Part 11, GxP requirements along with knowledge of GAMP, GDP
CSV (Computer System Validation) SOPs, SDLC and testing processes
LS COTS products (Trackwise, Documentum, Veeva, LIMS, LMS, CTMS etc)
Experience in Creating/Reviewing Validation documents across the Validation Life Cycle like Validation Plan, Protocols (IQ,OQ,PQ), Incident Report, RTM, Validation Summary Report
GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting
Working with Test Management tools (HP ALM/Jira/Bugzilla)
Performing estimations for Validation and Testing activities o Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
Experience in Daily/Weekly status reporting
Risk Management & Timely Communication
Must possess formal training/certification on Testing & Validation
Should be able to work independently with minimum supervision
Should have worked in cross-functional environments and comfortable to liaison with business

155

Note Validation Resume Examples & Samples

High School Diploma or equivalent required
College degree preferred
Minimum of three (3) years of experience in mortgage banking required
Strong verbal and written communication skills
Analytical, with an ability to identify and resolve problems
Well organized, paying close attention to detail
Ability to manage multiple priorities in a timely manner
Ability to meet the needs of internal and external customers by delivering high quality service
Rapidly adapts to changing information, conditions and/or unexpected obstacles
Strong interpersonal skills
Operates effectively in a team environment as well as independently
Proficient with Microsoft Office products (e.g. Word, Excel, Outlook, Powerpoint, etc.)
Proficiency with Mortgage Servicing Platforms (e.g. Black Knight, LPS, etc.) preferred
Proficiency with Adobe Writer preferred

156

Validation & Verification Engineer Resume Examples & Samples

Design, develop, review and execute test cases and procedures
Perform verification testing, track and report on progress, document incidents found, ensure test completion, review results, and generate reports
Participate in the planning and lead the execution of Verification testing activities in support of assigned projects
Coordinates with other Verification Engineers on Verification test activities
Participates in the creation and review of Functional Requirements for technical accuracy and testability
Work closely with all engineering disciplines as well as Project Management, Product Management and RA/QA personnel
Specify, design, and develop test systems and fixtures and other duties as assigned
Experience developing verification test cases, procedures, plans, analyzing test results, and writing reports is required
Experience in a test lead capacity and managing a project’s verification efforts is required
Knowledge of software development life cycle, software design verification and related activities
Hands-on experience with designing, building, and maintaining test fixtures and/or working with external laboratories to perform testing is preferred
Experience with in requirements management (including technical content reviews), design reviews, test reviews, and change control activities is preferred
Knowledge of Medical Device/FDA Regulated Industry and compliance with IEC-60601, 62304, ISO14971, 62366 preferred
Strong knowledge of Microsoft Windows and Office products is required
Working experience on setting up lab test equipment, setting up computer workstations and deploying software onto target systems is preferred
Experience using Requirements, Test Case and Incident Management tools (e.g. – Jama, DOORS, JIRA) is required
Bachelor’s degree in engineering, computer science or other technical field required
At least 5 years of experience in system-level verification testing in a regulated industry; experience in a medical device industry (21 CFR Part 820.30, ISO13485) preferred

157

Senior Manager, Verification & Validation Resume Examples & Samples

BS in Engineering with strong background in electronics and software
8+ years of progressive quality engineering/management responsibility
5+ years of medical device experience
Working knowledge of, and auditing experience to, the FDA Quality System
Regulation, ISO 13485, IEC 62304, Design Controls and the Medical Device Directive
Experienced in product risk management to the requirements of ISO 14971
Skilled in statistical methods, statistical process control and sampling plans
Good decision making skills Preferred Qualifications
Familiar with reliability analysis and test methods
ASQ Certified Quality Engineer or Certified Software Quality Engineer preferred
Six Sigma or Lean Certification(s) desired
Working knowledge of IEC 62304

158

Senior Engineer Validation Resume Examples & Samples

Writes validation protocols and final reports (IQ, OQ and PQ)
Documents and reviews standard operating procedures (SOPs)
Coordinates the proper approval of plans and protocols
Mentors new team members and assists in the training of validation execution
Supports regulatory inspections or audits
Tracks and coordinates validation change control and/or corrective actions
Serves as information resource for validation technicians, contractors and vendors
Represents department in cross-functional teams, projects and GXP-related problem resolution. Ability to sit or stand for extended periods of time Finger dexterity sufficient to use a computer and to complete paperwork activitiesHearing sufficient to communicate with individuals by telephone and in person Ability to gown aseptically for work in Clean Room environmentsMust have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials
Regularly lift 10-20 lbs. and occasionally lift up to 50 lbs
Job performed in a lab, office, or utility (noisy) environment
May be required to work alternate shifts
Vision sufficient to use a computer, to read written materials and to complete paperwork activities
Intermittent walking to gain access to work areas
Typically 4-5 years related experience in cGMP/FDA regulated industry
Knowledge of cGMP/QSR and FDA device/drug/biologics regulations
Bachelor’s degree in a scientific or engineering discipline or equivalent
Ability to gown aseptically for work in Clean Room environments

159

Snr Validation Engineer Resume Examples & Samples

Equipment Qualification and Process Validation
Facility & Utility Validation
Method Validation
Have knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities
Participate on both Corporate and Divisional Validation Teams to discuss/feedback and approve revisions to Validation Procedures
Represent validation at both internal and external audits
Ensure that QE’s and Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects
Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state
Ensure that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements
Review/Approval of Validation/Qualification Documentation
Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required
Assist in the evaluation of the validation status of contract manufacturers and provide guidance where needed. Review validation documentation from contract vendors ensuring that company requirements are met
Work with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures

160

Associate Validation Engineer Resume Examples & Samples

Perform validation software testing for telematics devices and infotainment system
Analyze validation testing data to determine if the product meets validation requirements
Understand technical specifications and be able to develop test scenarios to validate the system based on the technical specification
Analyze and understand flow charts to be able to create system level test procedures to perform validation testing
Lead issue reporting and communicate software issues to the development team
Track open software issues and verify solutions have been implemented in the next software release
Maintain and reinforce the test plan database for specification and requirement changes.

161

Clinical Validation Engineer Resume Examples & Samples

Manage all departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services
Manage all equipment, facility and utilities validation activities
As member of the Validation Review Boards interface with area managers from the Operations, Technics and Quality functions

162

Validation Associate Resume Examples & Samples

Writes and executes installation, operational and performance qualification protocols for critical production equipment, utilities and processes which may include: HVAC systems, clean compressed air systems, WFI systems, purified water systems, clean steam systems, nitrogen systems, fermenters, purification skids, vial washers, controlled storage units, autoclaves, depyrogenation ovens, SIP processes, and critical production equipment
Writes detailed validation reports and analyzes complex quality data
Uses Kaye Validator and/or data loggers for temperature mapping controlled storage units, SIP processes, autoclave qualifications and depyrogenation qualifications
Maintains revalidation schedules ensuring the facility remains in a validated state
Writes and reviews SOP’s related to qualification activities
Works directly with clients to understand and create qualifications
Reviews vendor supplied protocols and documentation for accuracy and compliance with internal requirements
May train lower level personnel
Troubleshoots and rectifies issues that are complex in nature
Works closely with cross-functional departments as necessary to resolve issues

163

Lead Validation Engineer Resume Examples & Samples

Areas of expertise include validation of cGMP computerized systems within an FDA regulated environment
Comprehensive knowledge of Validation lifecycles for site and global systems (i.e., IT, Analytical Equipment, Spreadsheets, SaaS (Software as a Service), Oracle, Trackwise, Maximo)
Practical experience with quality risk management and risk based validation approaches
Thorough understanding of industry standards and best practices computer system validation such as GAMP 5 and ASTM E2500
Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10
Demonstrated Project Management abilities to lead and manage a high volume of simultaneous projects
Excellent written and verbal communications, including technical writing. Microsoft Office Software, with MS Project

164

Lead Validation Engineer Resume Examples & Samples

The Lead Validation Engineer represents the Validation Department as a leader and contributor during validation projects with site strategic impact. This includes support of new and renovated equipment, facilities, and utilities as well as process and cleaning validations for clinical and commercial scale manufacturing of oral solid and parenteral dosage forms. (60%)
Perform and lead Risk Assessment exercises in support of validation activities (10%)
Perform formal challenges and time-based assessments as needed. (10%)
Lead and provide support to manufacturing to ensure testing is executed as intended. (10%)
Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, product, process and cleaning validation. (5%)
Be a resource to other departments for product and process knowledge. (5%)
5 - 8 years relevant experience in pharmaceutical validation area with experience in validation of equipment and facilities for manufacture of oral dosage forms
Consistently demonstrated validation proficiency with advanced knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation
Experienced in current validation trends and processes

165

Validation Coordinator Resume Examples & Samples

Maintain an accurate record of the validation review cycles and initiate the review with necessary engineering personnel. Routinely meet with the responsible parties to ensure progress is being made against the required schedule. Compile all necessary information and acquire approval signatures and file information in compliance with procedures
Provide validation administration services which include keeping track of the status of validation protocols and CSCP's and initiating the collection of data, drawings and procedures in order to complete the required activities on a timely and accurate basis. Proper filing of the above documents is a critical component of this activity. In order to accomplish this task the incumbent must have knowledge of the applicable procedures and the ability to work with others to acquire the necessary information
Procedure Management requires that the incumbent work with Idea for COM to initiate, route and complete SOP's within the ISEE group for periodic updates. At times this task will also require meeting with a project team to assist in the development or modification of SOP's
Master Data Management for SAP and Beamex includes the accurate collection review and entry of equipment and instrument data into the SAP PM and Beamex systems respectively. This task requires a familiarity with preventive maintenance and calibration administration as well as the equipment involved
The incumbent will be called upon to assist with the development and introduction of new ISEE service delivery models aimed at improving the overall level of compliance and efficiency. This incumbent’s responsibility with this role will be to work within teams comprised of R&D and ISEE personnel to develop data collection and entry procedures and to enter the data into the respective system
Strong Knowledge of GxP Regulations and application of these regulations to field operations

166

Manager Validation Lifecycle Mgmt Resume Examples & Samples

Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in scientific, engineering, or technical discipline, or its equivalent and applicable industry experience
A minimum of 10 years directly relevant experience in validation and/or quality engineering of process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in a biologics manufacturing facility
Proven experience in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics manufacturing facility
Extensive knowledge in establishing site and program validation strategies that are aligned with current industry mindsets
Direct experience with Board Of Health (BOH) Inspectors, External Auditors. Corporate and Internal Auditors presenting validation philosophies, strategies and executed testing
Previous managerial experience which demonstrates proficiency in selection, motivating and retaining a superior team
A working understanding of lean principles and establishment of effective process metrics is preferred
1601394

167

Biopharmaceutical Associate Validation Engineer Resume Examples & Samples

The Associate Validation Engineer executes and supports validation efforts associated with the operation of all GMP manufacturing systems
Primary areas of focus include validation of automated systems, cleaning validation, steam in place validation, and periodic assessment / revalidation activities
Executes the testing of required configuration changes to the site Process Automation System (Delta V)
Executes the testing of process recipes in the site Manufacturing Execution System (Syncade)
Supports validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs
Supports multiple projects and technical work assignments as interfaces with project stakeholders
Duties may include internal compliance or efficiency improvement efforts within department
Professionalism and technical competency required to represent the department before our stakeholders, and management
Demonstrated proficiency in oral communication and technical writing skills
Demonstrated proficiency in project management
Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent is preferred
Minimum of 4 years’ experience with biopharmaceutical / pharmaceutical industry in the areas of biopharmaceutical operations and cGMP
Previous experience in one or more of the following items is preferred
1603566

168

Biopharmaceutical Assistant Validation Engineer Resume Examples & Samples

Execution of testing of required changes to the site Process Automation System (Delta V)
Execution of testing of process recipes for the Manufacturing Execution System (Syncade)
Maintains familiarity with BMS directives and industry guidelines on qualification/validation
Demonstrated effectiveness in both a team environment and an individual contributor role
Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical or mechanical preferred), a related discipline, or its equivalent is required
Co-op or internship experience in biopharmaceutical industry including experience with manufacturing equipment support in the Biotechnology manufacturing industry is desired
1603599

169

Biopharmaceutical Validation Engineer Resume Examples & Samples

Primary point of contact for project and capital teams for deliverables to ensure validated state is established and maintained for equipment, utilities and facilities at the Devens site
Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, schedule requirements, require coordination with customers, collaborators, and quality
Responsible to deliver validation projects under strict deadlines to ensure customer success and bulk drug supply
Works collaboratively with multidisciplinary teams
Engineer works within the Validation group responsible for installation, operational and performance qualification (IQ/OQ/PQ) of process equipment, validation of SIP/CIP processes, validation of critical process equipment & utility systems, validation of process automation systems and manufacturing execution system recipes
Works with project teams to provide cost estimates for validation activities required by the scope of the project
Identifies validation resource requirements for projects and effectively manages validation project resources
Ensure alignment with BMS directives and industry guidelines on validation
Supports department in providing consistent estimates for resource estimates for non-capital projects
Develops and maintains KPI metrics for adherence to plan
Knowledge of engineering generally attained through studies resulting in a Bachelor of Science degree in engineering, related discipline, or its equivalent is preferred
A minimum of 6 years of experience in validation of process equipment, computer systems, manufacturing process control systems (automation) OR laboratory instrumentation in a biologics manufacturing facility is required
Experience with project management, planning and scheduling projects required
Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts
A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required
1603556

170

Biopharmaceutical Validation Engineer Resume Examples & Samples

Leads the testing of process recipes in the site Manufacturing Execution System (Syncade)
Develops appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel projects
Leads multiple projects and technical work assignments as a point of contact for project stakeholders
Provides validation subject matter expertise to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies
Duties may include internal compliance or efficiency improvement efforts within department
Minimum of 6 years’ experience with biopharmaceutical / pharmaceutical processing including testing and/or developing process automation system software
Demonstrated proficiency in oral communication and technical writing skills
Experience with cleaning validation
Knowledge of a system life cycle validation techniques for automation software specification and development
Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment
Professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management
Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent preferred
A minimum of 6 years of experience in validation of process equipment, computer systems, manufacturing process control systems (automation) OR laboratory instrumentation in a biologics manufacturing facility
1603568

171

Manager, Robustness & Validation Statistics Resume Examples & Samples

The ideal candidate will have a strong scientific background with an understanding of pharmaceutical/biotech or manufacturing operations
Advanced degree in Statistics, Science and/or Engineering disciplines
At least 5 years of experience and track record in innovative data analysis including multi-variate, attributes acceptance sampling, bayesian and the application of various statistical tools to ensure process understanding and control
Experience in statistical software and any associated programming for mini-tab, JMP, R, UMetrics, ChemLab, SASS, etc desirable
Significant change management experience to understand and lead the development of new capabilities
Experience in managing, developing, engaging and motivating people
Green/Black belt or equivalent sigma certification; knowledge of statistical process control, multivariate analysis, real time release, process analytics
Ability to lead and influence multidisciplinary, cross-functional teams
Ability to critically assess overall risk to project timelines/plans and resolve or escalate appropriately
Demonstrated (complex) project management leadership and innovative thinking
Knowledge in cGMP compliance, change management methodology, and product regulatory requirements
1602625

172

Biodefense Laboratory Validation Engineer Resume Examples & Samples

Development, execution, data analysis and reporting of validation and qualification activities for laboratory instrumentation to meet GLP requirements
Employ a risk-based approach to qualification and validation activities, including a validation maintenance program
Under general supervision, review and provide authorization when justified for proposed changes to qualified/ validated systems. Identify the qualification/ validation requirements necessary to maintain the system’s validated status
Track and report to testing facility management on status of qualification/ validation activities and assists Chief, Non-clinical Development Division on capital improvement initiatives
Provide validation metrics and business analyses for budget and resource planning to division management and above as required
Work closely with the USAMRIID Transition Office, end-users and other key stakeholders to develop and effective plan for transitioning existing/new equipment associated with USAMRIID’s GLP infrastructure into the new USAMRIID
B.S. in Chemical or Mechanical Engineering or similar scientific discipline preferred
3 years laboratory experience in the pharmaceutical industry
Preference will be given to candidates with relevant equipment qualification/validation experience in the pharmaceutical industry
MS combined with above experience preferred
Candidates with 10-12 years of relevant equipment qualification/validation experience in the pharmaceutical industry will also be considered

173

IT Validation Engineer GxP Processes Resume Examples & Samples

Author Validation and Qualification Plans in compliance with Dynavax’s Computer System Validation and Qualification Process and Procedures.Work with Dynavax staff to define Business and IT requirements and create Requirements and Specification documents such as User Requirements Specifications, Functional Requirements Specifications and Design Specifications. Participate in review sessions of URS, FRS and DS; incorporate comments and/or changes, as applicable.Manage the Risk Management process by authoring Risk Management Plan; ensure that the tests and other controls are in place to mitigate the Risks. Author the Risk Management Summary Report to ensure that the Risk controls are tested
Work with Dynavax staff, contractors and vendor resources to develop and execute Test protocols such as Installation Qualification, Operational Qualification and Performance Qualification to ensure that the system is configured and installed to meet specified requirements. Participate in review sessions of IQ, OQ and PQ protocols to incorporate comments and/or changes, as applicable
Work closely with IT and functional subject matter experts (SMEs) to determine the content for SOPs, WIs and forms. Participate in review sessions of SOPs, WIs, and forms to incorporate comments and/or changes, as applicable
Work closely with IT and appropriate Business and QA functions to assist with Change Control, Issue Management and CA/PA (Corrective Action and Preventative Action) documentation authoring and execution
Work with IT staff and management to author and update IT policies including IT Security policies
Complete assignments in accordance with set standards related to format, order, clarity, conciseness, style and terminology
Provide status updates on all documentation milestones
Work with project teams to identify, analyze, prioritize, document and communicate project risks to mitigate impact to project deliverables and timeline
Perform miscellaneous other duties as assigned
Bachelor's degree in Computer Science or other technology related field or an equivalent combination of education and experience
Three or more years of IT Computer System Validation and Qualification experience in a pharmaceutical company
Must have demonstrated hands-on experience in full lifecycle from system requirements and specification phase, to design and implementation phase, and operational phase of computer system validation and qualification
Must possess the ability to quickly develop and maintain a high level of knowledge and understanding of Dynavax’s existing solutions and documentation
Requires a very good understanding of CFR part 11 and GAMP5 provisions as they apply to systems management and deployment
Any experience in developing or updating IT Security Policies will be a plus
Must be resourceful with a strong customer-service orientation and commitment to provide timely and quality solutions to customer issues
Demonstrated excellent written and verbal communication skills. An effective listener able to convey information in an accurate and concise manner and understands when to seek feedback
Effective presentation skills with the ability to deliver information to a broad range of audience
Must be well-organized, self-directed, and a team player
Highly effective in prioritizing and organizing work plans and activities to deliver on objectives on time and within budget
Must be detail oriented, with strong analytical and problem solving skills, and to effectively research, troubleshoot, and solve challenging problems involving integrated systems
Must possess a strong understanding of business processes related to pharmaceutical corporate activities

174

IT Validation Engineer Resume Examples & Samples

Executes System Configurations, Installation Qualifications, and Test Scripts as needed
Performs quality control reviews of validation documentation for computer systems, including
HS/GED with 4 to 6 years of relevant experience; contract research organization experience
Demonstrated ability to lead multiple projects with tight timelines
Demonstrated knowledge of 21 CFR Part 11 assessments
Ability to communicate verbally and in writing at all levels inside and outside the organization
Basic familiarity with Microsoft Office Suite
Computer skills, commensurate with Essential Functions, including the ability to learn a validated

175

Process Engineer, Validation Resume Examples & Samples

Generate and review validation risk assessments (utilizing statistical analysis) and determine re-validation or qualification needs
Technically write complex validation and addendum validation protocols and reports
Collect, table, and analyze the generated data for the validation reports
Interpret and draw conclusions to establish and defend the validation status of a process and identify trends
Work with other departments to discuss the validation status of products and reports. Present findings to leadership within the group
Assist in writing and reviewing SOPs related to or affecting process validation
Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. A Master’s degree (or equivalent) and 2 years of experience preferred. However, a combination of experience and/or education will be taken into consideration. Process Validation experience is preferred
Must possess solid working knowledge of cGMPs, Standard Operating Procedures, FDA regulations, and FDA Guidances. Knowledge of process validation requirements for non-U.S. marketed products is required. Must understand and adhere to company and department procedures and policies
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence
Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments
Must possess strong problem solving, communication, analytical and technical writing skills. Must be detail oriented and have the ability to multi task and perform multiple projects/tasks simultaneously. Must have good leadership/management skills
Must possess computer skills and have a working knowledge of Microsoft Office Suite, Documentum, TrackWise, LIMS, SAP, and Lotus Notes
Ability to perform computations such as percentages, ratios, and rates
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems

176

Manufacturing Project Associate Engineering & Validation Resume Examples & Samples

Coordinate and track cross-functional projects from origination to completion which involves working with the following groups: manufacturing, manufacturing support. engineering, facilities, automation, and validation
Ensure that any and all impacts to existing systems, equipment, and processes are understood and controlled throughout all engineering projects
Assist with scheduling engineering and validation projects based on equipment availability and project timelines
Work closely with the validation group to ensure that all timelines and testing requirements are being met
Utilizes tools and mechanisms to ensure global alignment of commercial manufacturing’s processes, procedure and methods
Develop and track metrics to measure performance and improve efficiency
Prepares, distributes & presents project status reports to management
Successfully manage the relationship with all stakeholders
Create and maintain comprehensive project documentation
Conduct clear and concise project meetings
Ability to build effective working relationships throughout the organization
Ability to operate independently within a tight deadline environment
Is a high energy self-starter with a resilient, can-do attitude
Ability to adapt to a quickly changing environment
BS/BA in Engineering or related field required with 4+ years of relevant experience. MS in similar field preferred
Experience in biotech manufacturing is preferred
Experience with project management preferred

177

Senior Mgr / Mgr Computer Systems Validation Resume Examples & Samples

Provide guidance and direction on Computer Validation matters
Promotes a GxP and Quality mindset at all levels
Creates and maintains a strong relationship with the leadership team and participates in all appropriate meetings and venues
Work with Validation Management to ensure appropriate execution of validation strategies and compliance with internal procedures
Ensures that all quality based deliverables are complying with regulatory and quality policies and procedures and timelines are met and observations are corrected
Manages staff as assigned to work with project teams on their quality deliverables
Ensures direct-report staff is appropriately resourced, supported and has the tools and direction to properly execute their function
Keeps current on changes to all regulatory requirements and, with other members of the Quality team, facilitates implementation into Regeneron systems
Participates in regulatory audits and communicates company's computer validation policies
Assesses company's computer systems and identifies any potential Part 11, Annex 11, data integrity gaps
Coaches, develops and mentors direct reports
Ensures safety and operational standards
Requires BS/BA in Engineering, Chemistry, or Life Sciences with 10+ years’ experience in the pharmaceutical/biotechnology industry (biotech preferred) within the fields of IT, Automation or Validation. A minimum of 5+ years in Validation is required
Prior experience in a managerial capacity, as well as technical experience in a relevant operations function
Experience with distributed control systems, programmable logic controllers, batch control system standards, software development methodologies, and automated system lifecycle support in the pharmaceutical industry
Experience with requirements analysis, system design, implementation and validation of manufacturing execution and batch control systems in 21 CFR Part 11/Annex 11 compliant GMP manufacturing environments in the pharmaceutical industry
Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5

178

Manager Quality Validation Resume Examples & Samples

People Skills
Bachelor’s Degree in Science OR Engineering
3+ years’ experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment

179

Director Corporate Commissioning Qualification & Validation Resume Examples & Samples

Analyze current site processes, procedures and best practices of the Operational Organizations at each SCO manufacturing site that develops, manages and/or executes activities within the engineering and Validation life cycles that deal with the Commissioning and Qualification / Verification process as defined in corporate Genzyme and Sanofi Quality and Engineering standards
Network with Sanofi sites to gain understanding of site processes, procedures and best practices at manufacturing sites that develop, manage and/or execute activities within the engineering and Validation life cycles that deal with the Commissioning and Qualification / Verification processes
Network with industrial organizations (e.g. PDA, ISPE) to gain understanding of processes, procedures and best practices at manufacturing sites that develop, manage and/or execute activities within the engineering and Validation life cycles that deal with the Commissioning and Qualification / Verification processes. Incorporate this input into the SCO Engineering Commissioning and Qualification/Verification documents as appropriate. Also communicate these, as appropriate, to the SCO site organizations handling Commissioning and Qualification / Verification activities
Act as a liaison between Corporate Quality Operations, SCO Engineering, site engineering, site validation on Commissioning and Qualification / Verification related subjects
Review and approve Commissioning and Qualification / Verification Plans for large capital projects at any of the SCO sites
Create action plans for the standardization / harmonization of best practices in C&Q with the implementation of the standards, guidelines, and SOPs to be used consistently at all SCO manufacturing sites
Work directly with the functional head(s) of operational units at each site to integrate Commissioning and Qualification / Verification best practices with on-going programs throughout the SCO network
Assist site heads and functional leaders in establishing a strong quality culture of Right-First-Time and continuous improvement in regards to Commissioning and Qualification / Verification/Validation processes and practices
Make determinations regarding standardization of specific process or practice for C&Q across SCO sites and assist the site with implementation
Provide direction and oversight in the design of the SCO Commissioning and Qualification / Verification/Validation system for a functional area and for the working performance of the system itself. The system will include the data collection methods, data collection criteria/metrics for accuracy and timeliness of documentation, process flows, key activities, hand-offs, process capacity, process outputs, specifications for output quality, in-process control metrics to indicate if a process is drifting out of control and results/metrics that indicate if the process meets the required technical and business targets
Conduct quarterly, SIPOC-based, system reviews with the Site Process Owners to evaluate how well the system is performing
Bachelor’s degree in a science or engineering field
Minimum of 15 years of experience in engineering field of which 10 are with some Biotech exposure
Minimum of 10 years of experience with validation, commissioning and qualification of products in a regulated environment
Experience with site engineering role and also to a large CAPEx project
Experience working with U.S. and European GMP requirements
Experience working in a biotechnology, pharmaceutical or regulated environment
Experience leading teams

180

Manager Sterilization Validation Maintenance Resume Examples & Samples

Plan, coordinate review, approve and manage the validation and re-validation personnel and activities to support Industrial Operations and R&D for Sterilization, Decontamination and Depyrogenation processes for the Technical Services SVM Group
Provide scientifically sound analysis, discussions and recommendations where required for troubleshooting and investigative roles for all Quality Systems
Represent Sanofi Pasteur during Regulatory, Corporate or Internal inspections or activities
Manage sterilization re-validation & validation projects including
Working knowledge of Sterilizing and Decontamination unit operations
A familiarity with Regulatory Requirements for the vaccine industry
Excellent Written and Verbal communication skill Working knowledge of troubleshooting methodology
Professional certification will be an asset

181

Quality Validation Lifecycle Management Associate Resume Examples & Samples

Manage activities to support the validation lifecycle of GxP computerized systems
Ensure GxP computerized systems are validated and controlled to comply with US and EU GxP regulations and ICH Q7 guidelines
Lead / facilitate development of sound risk based test strategies and plans
Develop strategies to optimize and improve the computerized system validation program consistent with operational and compliance needs
Assist staff in the reporting and evaluation of data to be used for trending and monitoring the validation process
Provide validation support for audits and inspections, as needed
BS/MS degree in a related field with 5+ years of relevant industry experience
Strong working knowledge of computerized system validation following industry standards (GAMP), and cGMP is required, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
Prior QA experience preferred
Previous experience working with change management systems
Previous audit experience is highly desired
Enthusiasm for the work and ability to proactively implement continual improvements
Proven ability to work effectively in a fast paced team environment
Ability to organize information in a consistent and readily retrievable manner
Prior experience applying risk assessments to validation projects
Position requires ability to travel periodically (US/International, < 10% of time)

182

Validation Associate Resume Examples & Samples

IND123
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Solid understanding of design control process
Ability to create Functional Test Scripts/Test Cases to show

183

Principal Validation Engineer Computerized Systems Resume Examples & Samples

Defining validation strategies and oversight through the implementation of validations plans for site based computer systems
Sound industry knowledge, project proficiency, and autonomy expected. Considered a validation Subject Matter Expert (SME) in the areas of plant automation and process control systems, QC Chemistry and microbiology systems, metrology business systems and IT infrastructure
Expertise in Software Development Life Cycle (SDLC), 21 CFR Part 11, EU's Annex 11, and GAMP® 5 requirements
Lead risk assessments to identify critical SDLC activities and deliverables during the implementation and validation of various computer systems
Plan computer validation projects and track execution of validation activities versus project timeline. Manage and plan the work of the internal and contract resources
Perform change control assessments and write/review validation plans, qualification protocols and summary reports. Manage the execution of qualification protocols and review test results
Supporting development of best demonstrated validation practices within the validation department, based on current industry practices and regulatory guidelines
Working knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, EU's Annex 11 guidelines and other international regulatory requirements
Have previous validation experience in Rockwell Automation, FTView SE, ControlLogix, FTBatch, SQL Databases and OSI Pi as well as lab equipment and software such as QC LIMS and Empower, building automation, and IT infrastructure
Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in related disciplines
Lead and manage various validation activities and author/review related documents including validation plans, risk assessments, 21 CFR compliance assessments, qualification protocols, and summary reports
Lead qualification protocol execution, and manage protocol deviations investigation and corrective action activities
Participate in user/system requirements gathering, design qualification, and CAPA investigations
Collaborate closely with supplier quality and system owners in defining the role of software suppliers. Assist in evaluation and oversight of supplier activities and documentation related to system qualification
Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Able to establish and manage multiple cross-functional teams simultaneously

184

Principal Validation Engineer Resume Examples & Samples

Defining CQV strategies and oversight through the implementation of CQV plans for plant utilities, facilities and process equipment
Lead and perform variety of CQV projects/studies in areas that may include Product/Process, sterilization, Cleaning verification and Equipment commissioning and qualification, as well as projects/studies to support manufacturing
Plan CQV projects and track execution of CQV activities/documentation versus project timeline. Manage and plan work of the internal and contract resources
Perform change control assessments and write/review CQV plans, study/test protocols, and summary reports. Manage execution of study/test protocols and review test results
Collaborate closely with Engineering and Process sciences in defining the role of suppliers with the assessment of suppliers and oversight of supplier activities and documentation related to Commissioning activities
Mentor junior staff in their job performance and project related activities
Minimum of a BS in Sciences/Engineering (other degrees accepted provided the individual has relevant experience
Minimum of 5-8 years’ relevant experience within the pharmaceutical, biotechnology or biopharmaceutical industry with 2-3 years experience in leading resources and projects
Working knowledge of cGMP guidelines, FDA 21 CFR Part 210/211, ICH guidelines and other international regulatory requirements
Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in commissioning and qualification for plant utilities, facilities and process equipment
Lead various CQV activities and author/review related documents including CQV plans, design qualification reports, traceability matrices, commissioning and qualification protocols, and summary reports
Participate in CAPA investigations, design reviews and product/system based risk assessments
Have excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel
Demonstrate ability to comprehend mechanical/electrical drawings and related engineering prints for CQV activities

185

Robot Validation Engineer Resume Examples & Samples

Responsible for the software development used when robot verification and validation
Collaborate with other colleagues to improve the validation process by software
Responsible for the development of robot validation software in both in-house production and EMS production
Coordinate with project and production on the robot validation, to improve the design and production quality

186

Manufacturing Data Validation Engineer Resume Examples & Samples

Provide support on projects involving multiple cross-functional teams, focusing on delivery of local program work packages, within prescribed time frame from initiation through delivery
Design build, assembly, and calibration processes on new, prototype or existing equipment
Create, configure, and maintain product eBOM and mBOM structures in Teamcenter
Support workflow processes to create item master records from CAD objects
Create and configure master EBOM and master MBOMs from parent CAD structures
Check Engineering Change Notices (ECN’s) for complete and correct information and content
Compare mBOMs with eBOMs and serve on development team to automate this process
Use TC Configurator to generate specific product mBOMs for release of all product SKUs
Ensure quality control and assurance and Identify solutions to technical design problems
Collaborate with design engineering and manufacturing engineering on establishing and sustaining rules for data transfers
Internship to 5 years of data analysis experience
Internship to 5 years of experience in a manufacturing setting
Advanced Excel knowledge; ability to use VLOOKUP
Prior hands on work with Teamcenter, specifically with eBOMs and mBOMs
Experience working with CAD software, specifically Creo

187

Vital Validation NI Labview Engineer Resume Examples & Samples

Develop automated and manual based simulators in LabView with access via TestStand
Basic understanding of requirements based testing
Ensure documentary evidence of tests created, updated, and executed through configuration management control via change requests, CCBs (Change Control Boards), etc
Min 1-2 years’ experience with LabView & TestStand
Bachelor's Degree in Electrical Engineering or Computer Science/Engineering, or equivalent combination of education and experience
Minimum experience in System Testing Processes, Tools, and Automation
LabVIEW and/or TestStand certifications
Employee Referral Bonus Eligible*

188

Lead Vital Validation NI Labview & Veristand Engineer Resume Examples & Samples

Ensure compliance and evidence, for which your team is responsible is developed, archived under CM control, and according to certification requirements
Establishing a project schedule and ensuring execution of commitments, including identification and escalation of risks for test simulation environments
Certified Labview Developer certification
Certified TestStand Developer certification
Major experience of 5+ years of experience in NI LabView Development Environment including Real-Time and FPGA Modules, preferably CompactRIO
Min 3+ years of experience with NI TestStand development
Min 1-2 years of experience with NI VeriStand development
Working knowledge in SW configuration management and defect tracking
At min Bachelors Degree of Engineering
Certified LabVIEW Architect
Certified LabVIEW Embedded Developer
Certified TestStand Architect
Experience with System Testing Processes, Tools, & Automation
Ability to creatively solve complex problems
Ability to work in a cross-functional, global environment
* Relocation available***

189

Senior Quality / Validation Process Engineer Resume Examples & Samples

Collaborating with new product development groups to define and document risk assessments, test methods, and V&V protocols to ensure cGMP adherence of designs and products
Defining, documenting, performing, and analyzing verification and validation tests for products and accessories
Leading and/or supporting ISO 13485 quality system projects, including creation or revision of site Standard Operating Procedures
Facilitating and owning the diagnosis and resolution of related product, process and system problems using analytical and project management quality tools and best practices, (e.g., DMAIC process, Six Sigma body of knowledge, statistical process control, charting, Pareto, 8D, etc.)with cross-functional team members
Supporting the organization's new technology development, continuation engineering and risk based approach using tools such as Failure Mode and Effect Analysis (FMEA)
Coordinating and conducting supplier assessments with supply chain and/or quality management as defined per audit schedule
Proactively participating in creation and/or updating of budget, scorecard and objectives for the upcoming year(s)
Making and upholding difficult decisions
Ability to travel 15-20%, domestically
Bachelor of Science degree or equivalent in technical discipline; engineering or materials, with professional experience in the Medical Device or Biopharmaceutical markets
Quality Engineer certification (CQE), Six Sigma Green, Brown or Black Belt
Demonstrated leadership role in Validation or issue ownership including ability to provide guidance and direction to less experienced technical personnel, as required
Strong Mechanical and Systems aptitude with an eagerness to take a hands-on approach
Technical expertise, effective communication skills, creativity, and internal drive to lead the validation aspects of the Aramus System
Experience with or sound understanding of the Quality Management System standard and regulations, such as ISO 13485, 21 CFR Part 11, 21 CFR Part 211 and 21 CFR Part 820. Experience auditing to these standards is a plus

190

Dimensional Validation Engineer Resume Examples & Samples

Knowledge of Body-in-White (BIW) assembly processes
Ability to assemble and interpret large amounts of data in a production environment
Knowledge of SPC concepts
Knowledge of GD&T and gaging
Strong problem solving skills and ability to apply problem solving tools
Degree in Mechanical or Metallurgical Engineering
Proficient in Microsoft Office Excel
Knowledge of hemming and weld processes
Knowledge of stamping processes
Familiar with part qualification and component quality requirements

191

Electrified System Development & Validation Engineer Resume Examples & Samples

Bachelor of Science in Electrical or Mechanical Engineering
Minimum of 5 years of experience with Powertrain E/E electrification validation development
Good understanding of powertrain electronics and engine technology
Proven DVP&R & DFMEA development
Work experience with Microsoft Excel, Word, and PowerPoint
Excellent automotive analytical and problem solving skills to troubleshoot complex issues
Demonstrated ability to work in a team environment
Master of Science in Electrical or Mechanical Engineering
Software controls experience
System integration and developing validation tests for electrification systems
Working experience with ETAS INCA software
Working experience with FCA's diagnostic tools
Working experience with Vector's CANalyzer or CANoe software programs

192

Engine Systems Validation Engineer Resume Examples & Samples

Bachelor of Science in Electrical, Mechanical, or System Engineering is required from an accredited university
Minimum of 6 months of experience. An advanced degree, internships / co-ops, and/or academic research in a related field may count towards experience requirement
Good understanding of verification and validation of powertrain control systems
Knowledgeable in CARB OBD and Federal Diagnostic requirements

193

System Development & Validation Engineer Resume Examples & Samples

Bachelor of Science in Electrical or Mechanical Engineering from an ABET accredited university
Minimum of 5 years of experience with automotive system validation or product development
Proven DVP&R and DFMEA development
Excellent analytical/problem solving skills to troubleshoot complex issues
Highly motivated/self-starter
Strong verbal/written communication skills
Master of Science in Applied Physics, Mechanical, Electrical, Aerospace, Industrial, or Computer Engineering, or related Engineering field from an ABET accredited university
Vehicle assembly manufacturing plant test experience
System integration/developing validation tests for electrification systems
Working experience with FCA's diagnostic tools (wiTECH or CDA)

194

Powertrain Validation Engineer Resume Examples & Samples

Serves as a Powertrain Validation Engineer subject matter expert for Summer & Winter vehicle testing with a strong focus on the Engine Aftertreatment System and Engine Cooling packages providing insight, development, and tracking of all related validation procedures and status
Leads, manages, coordinates, and orchestrates multi-vehicle offsite testing in harsh, remote environments with large teams of engineers, technicians, and drivers
Plans, coordinates, and conducts projects of a significant scope with minimal supervision
Analyzes project requests, discusses project requirements with requestors and formulates preliminary project plans, budgets, and schedules
Designs fixtures, specifies and oversees instrumentation, equipment, vehicles, loading configurations, software versions, and data processing techniques
Participates in set up of tests, verifies that test equipment and instrumentation equipment meets specified requirements and performs software and data checks
Participates in data collection and analysis
Writes reports, as appropriate, incorporating results, conclusions, and recommendations
Establishes and maintains cooperative and productive work relations with all other departments
Develop and maintain a high level of familiarity with PACCAR products and service tools
Present results of test or investigative projects to divisions or management personnel
Off-site testing requires up to 30% travel

195

VIE Chef de Projet Vérification & Validation Resume Examples & Samples

Secure that the projects deliver products that fulfil set product requirements
Assist product owner in defining appropriate requirements to cover customer environment and machine function
Support projects organization in managing project/product risks out of a V&V perspective (Concept selection, QDCF balance)
Mechanical engineering degree (or equivalent)
Project management basic understanding
Fluency in English, both spoken and written
General knowledge of off-road machine systems (construction, agricultural, for example)
Knowledge of software validation
Knowledge of test and analysis methods
Knowledge of reliability and durability theory
German Language & others
Statistics
Customer & business orientation
Excellent co-operation ability
Structured way of working
Learning from experience, continuous improvement
Courage & integrity
Ability to operate with cross-functional & multi-cultural project teams

196

Lead Validation Engineer Resume Examples & Samples

Board level debug and validation of NVIDIA's GPU based products
Create and maintain overall board validation plan. Identify and define test plans for unique/new features on each product
Review and approve engineering changes submitted by the lead design engineer and understand impact to validation plans
Analyze and recommend solutions to optimize the performance, cost, and time to market of our products
Drive all board level validation issues to closure using resources within the engineering team including hardware engineering and software engineering
Produce necessary lab equipment usage requirements based on current and future validation test plans for upcoming product qualifications
Key contributor to final validation qualification report required for external documentation
Help maintain high level of quality for validation engineering to support successful new product ramp
Contribute to the development of new validation procedures
Define diagnostics for engineering and production builds

197

Lead Validation Engineer Resume Examples & Samples

Perform post-silicon validation, characterization, software and system testing of high-end switching silicon device
Write a comprehensive validation test plan for MAC block of networking device
Qualify features like- Auto-negotiation, MAC/PCS Loopbacks, SERDES, Local and Remote faults, Interrupts, Reed-Solomon Forward Error Correction (RS FEC), Inter Frame Gap, 40G, 25G and 100G
Interoperability with networking devices and NICs from other vendors
Performance Validation of VLAN, ACL, IPv6, MPLS and Tunnel features
Develop automation in Python, execute test cases, and analyze/debug failures for functional, and performance tests
Execute and validate performance and scaling tests for networking device
Work with ASIC and SW development teams to report and resolve issues identified
Participate in code and design reviews
Ability to define problems, issues and opportunities, analyze data, establish facts, and draw valid conclusions from various datasets

198

Dir, Validation Architect Mgmt Resume Examples & Samples

At least 10 years of semiconductor and/or system validation experience
Must have experience in leading or serving as a principal engineer in validation organization
SSD validation experience is a plus
Experience with development of test infrastructure and test automation
A system approach and familiarity with systems engineering practices
In-depth knowledge and experience with implementations of SATA and PCIe/NVME is a plus
Fluent English (written & verbal)
An ability to work in a team and a wide international organization environment

199

Powertrain Validation Engineer Resume Examples & Samples

Serves as a Powertrain Validation, Software Manager and Subject Matter Expert, which requires comprehensive vehicle software understanding and hands-on technical experience
Plans, coordinates, manages and oversees all Powertrain Validation Software updates with minimal supervision
Requires in depth software technical experience, perseverance, patience, strong dedication and attention to detail to work through various dynamic software issues
Ensures the Powertrain Validation team is kept informed of all the applicable software changes
Leads the test setup, verifies that test equipment and instrumentation equipment meets specified requirements and performs software and data checks
Oversees and manages data collection and analysis
Off-site testing requires up to 10% travel
BS degree in appropriate engineering discipline
MS preferred
Minimum 6 months of truck/automotive powertrain hardware and software testing experience desired
Self-directed, excellent analysis and technical judgment required

200

NDT Validation Consultant Resume Examples & Samples

Able to complete standard inspection qualification tasks according to procedures without supervision
To prepare, review, comment and take the appropriate action regarding specifications, drawings and other documentation associated with the design and procurement of test pieces
To prepare, review, comment and take appropriate action regarding manufacturing and inspection documentation associated with qualification test pieces
Carry out or assist with internal and external audits
To assess and validate implementation of inspection procedures at customer manufacturing locations both within the UK and overseas
Responsible for monitoring the security of information at contractors’ works
To have a full understanding of the project requirements in detail by liaison with the appropriate responsible engineer
Provision of status and progress reports on a regular basis
Ensure that site and receipt inspection activities are carried out satisfactorily
Liaison with other associated departments/organisations both within and outside Amec Foster Wheeler
Degree or HNC in Engineering/ Science and/or Corporate Membership of a Professional Institution; alternatively experience and training of equivalent value would be considered
PCN qualifications in UT techniques at level 2 as a minimum and preferably at level 3
Producing qualification procedures in line with a standard ENIQ qualification similar to those generated for similar components
Providing comments on inspection procedures and technical justifications (TJs) produced by third parties
Witnessing and invigilating procedure and/or personnel qualification trials applying approved company procedures
Arranging trial schedule
Design of standard test pieces to meet the requirements of the qualification procedure
Production of standard inspection procedures (manual or automated)
Assessment of results from receipt inspection against test piece specification
Assessment of model results presented in TJs and for inspection design
Provide guidance and clarification to staff operating standard processes and techniques
Energy, enthusiasm and good communication skills
Proficient in the preparation of clear and concise written technical reports
Willingness and ability to travel with the possibility of extended periods away from home both in the UK and abroad

201

Intern on Cellular RF Performance Analysis & Validation Resume Examples & Samples

Line-up analysis of mobile receiver frontend
Uses and applies simulation tools and techniques to ensure performance to specification
Operation of radio frequency test equipment
Definition and development of system validation environment and test suites
Development of new test methodologies, execution of validation plans, and debug of failures
Master student with completed Bachelor of Engineering in Electronics and Communications or Radio Frequency Technology
Programming skills: Visual Basic for applications and Matlab
Knowledge in the field of communication (WLAN, GSM, UMTS, LTE)
Hands-on experience with lab equipment control is an advantage

202

Principal Validation Sde-isilon Performance Resume Examples & Samples

(Principal) Develop a holistic vision for building an automated validation implementation for the Isilon Statview and StatsD system components. Use your newly learned expertise to help other system performance validation efforts
Help guarantee a high quality solution by bringing your “quality first” mind set to the table; work with engineers to jointly develop unit, functional, and integration tests. Improve performance test automation, performance tooling, test reliability, and test coverage
Demonstrate excellent collaboration and communication skills as you obtain requirements, plan, build a detailed design, and deliver a high-quality implementation of your validation solutions
(Principal) Drive validation improvements across the rest of the Isilon engineering organization
Contribute visibly to the relentless pursuit of product quality, innovation, and customer-centric design across the engineering organization
Possess a strong aptitude for exploring new technologies and understanding how to apply them to new products, and system tools
BS in Computer Science or related technical field, and 4 (Senior) to 10 (Principal) years’ industry experience
Extensive experience with FreeBSD and/or Linux operating systems
Extensive experience developing or validating software with Python and C++ tool chains
Strong system engineering and system troubleshooting skills
Experience planning projects, documenting test designs and delivering software validation tools
Familiarity with statistics, system metrics, distributed services, databases, file systems, or storage/infrastructure is a plus

203

Engineer Validation, Senior Resume Examples & Samples

5+ years experience testing embedded firmware
Expertise creating test protocols designed to verify and validate the embedded systems
Extensive experience with Python and scripting languages
Solid experience with testing equipment and testing standards
Basic EE knowledge

204

Senior Validation Associate, Biopharma Resume Examples & Samples

Supports the process validation program
Develops and writes process validation procedures
Monitors regulatory and industry validation practices to assess our compliance
Interacts with the client and client team to define process validation scope
Designs and executes the appropriate development Technical Studies to define process parameters
Uses statistical tools to design and analyze technical study data
Creates a risk assessment of the process to be validated
Creates process validation protocols
Conducts or coordinates process validation activities
Prepares validation summaries
Uses statistical tools to analyze process validation data
Performs annual reviews of validation projects
Investigates and executes validation related Corrective and Preventive Actions
Performs validation related investigations as needed
Creates and maintains visual controls for Process Validation group
Serves as Subject Matter Expert (SME) for process validation·
Participates in client and regulatory inspections
Bachelor’s degree required, preferably in a science or engineering-related field
Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

205

Validation Associate Resume Examples & Samples

Plan, organize, execute and track multiple tasks of low to moderate complexity to ensure timely completion of deliverables related to key quality functions
Analyze data for routine validation and production documentation to determine acceptability, identify deviations and make appropriate notification
Approve routine validation and production documentation w/o deviations
Prepare documents and reports; gain multidisciplinary consensus with some degree of independence
Maintain and use database systems
Perform GMP audits and quality engineering activities related to process improvement
Prepare, retrieve and review documentation for customer and regulatory audits. Assist with presentation of data during customer and regulatory audits
Assess impact of changes of moderate complexity
Prepare documents for records archival

206

Validation Associate Resume Examples & Samples

Perform validation services with direction of supervision for Systems and Facilities Validation Team for completion of validation projects to support the schedule
Generate and/or follow quality compliance driven documentation to including performance of test protocols for systems, facilities, equipment, revalidation or periodic review activities. Analyze data for routine and production documentation to determine acceptability, identifying discrepancies and make appropriate notifications to management or supervision
Knowledge of Revalidation of Sterility Equipment and Systems, Periodic Reviews to include temperature/humidity mapping, DCS, SCADA and PLC driven equipment with the ability to adequately write and follow technical documentation and protocols is preferred
Proficient in Technical Writing skills and knowledge of MSOffice applications required
Attention to detail on documentation, testing, analysis of results, and decision making for compliance with industry standards meeting quality attributes and compliance are required
Project management and organizational skills to meet aggressive timelines preferred
Work as needed during and outside normal work hours as necessary to provide support to internal and external customers
Work in a safe and responsible manner in order to create an injury-free and incident-free workplace

207

Trade Validation Americas Resume Examples & Samples

Act as Client Service representative covering multiple clients, products and markets
Foster and maintain mutually beneficial client relationships
Facilitation of client matching, allocations & confirmation processing
Post execution trade booking and amendments
New account initiation / set-up
Reconciliations, Fails management escalation investigation
Research and resolution of all client and desk related ad-hoc queries
Participation in various business initiatives, projects and systems testing
Pro-active / positive attitude
Client focused
Control mindset
Solid team player
Excellent interpersonal and communication skills
Ability to multi-task in a fast paced, high pressure, high volume environment
Exceptional attention to detail
Analytical problem solver

208

Pre-si Validation Engineer Resume Examples & Samples

Validating design and micro-architectural implementation and assumptions
Creating, enhancing, or supporting software tools to improve validation quality
Automating validation tasks in order to complete the design block in the most efficient fashion possible
Methodical problem solving skills
Working knowledge of RTL coding (system Verilog, Verilog, vhdl, etc.)
Good knowledge of scripting languages such as Perl or Unix scripting (BASH, CSH)
Minimum of 3 months college experience with computer architecture and digital logic
Minimum of 3 months college experience with software/programming languages (i.e. C, C++, Perl, Python, Java, etc.)
Minimum of 3 months college experience with Unix/Linux

209

Platform Validation Engineering Intern Resume Examples & Samples

Defining and developing test tools and test automation
Defining and improving engineering processes to increase product quality and team efficiency
Exploration and implementation of new SW Engineering methodologies and technologies
Defining and executing test plans and test cases
Demonstrated script development experience (preferably Python, Bash, or Windows Batch)
Database development experience (preferably Microsoft SQL Server)
Experience building/integrating computers, including installing Operating Systems and device drivers is a benefit

210

Validation Technical Specialist Resume Examples & Samples

Responsible for reviewing and maintenance of Validation lifecycle documentation to ensure there is sufficient documented evidence to support product manufacturing in accordance with appropriate regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices
Provide technical writing & support to quality systems records including; Deviations, CAPAs, and Change Controls which are associated with validated systems
Provide sound scientific and compliance expertise during the development of cGMP validation documentation; i.e. protocols, reports, SOPs, etc
Responsible for evaluating and maintenance of validation and process data to support recommendations for changes and/or improvements to the process
Co-ordinate workshop sessions and develop knowledge sharing platforms supporting the Validation/Technical Departments and knowledge transfer across the site
Minimum of a Bachelor's degree (or equivalent) in a Technical Discipline with a minimum of 4 years’ post graduate experience in Technical Services / Manufacturing Support /Validation within a cGMP manufacturing environment in a biologics/ pharmaceutical setting
Direct experience within liquid & lyo fill finish technology is a strong plus
Must have knowledge of current industry best practice & validation requirements for pharmaceutical manufacturing processes
Proficiency in speaking, comprehending, reading and writing English is required

211

Independent Verification & Validation Resume Examples & Samples

Working closely with clients, subject matter experts and project team to understand requirements and establish priorities
Validation of IT products utilizing a broad range of development tools and technologies, including .Net 2.0 and above, C#, ASP.Net, XML/XSLT, and SQL Server 2008 and above
Reviewing application code and software architecture to identify deficiencies and making recommendations for improvements
Software Requirements specification, analysis, derivation, compliance assessments
Lead and participate in peer reviews
BS/BA in a technical field: Computer Science, Engineering or IT related discipline
10+ years of Microsoft development experience with a broad range of development tools and technologies, including C#, ASP.Net, XML/XSLT, Subversion source management
5+ database programming experience using SQL including hands-on experience with Microsoft SQL Server and SQL Server Integration Services
Demonstrated experience and understanding of software architecture including
Excellent understanding of Object-Oriented analysis and design
Demonstrated experience with Service Oriented Architecture
Ability to make technology and architecture decisions to meet client needs
Understanding of project and configuration management practices
Experience working with client executives, project managers, business analysts and other stakeholders to define and execute technical requirements from business requirements
Recognition and observance of industry-standard architectural and coding standards, an understanding of best-practices in software development, and familiarity with different SDLC processes and methodologies
High attention to detail and software quality. Specific QA/QC and testing experience a plus
Experience balancing and prioritizing multiple projects to meet goals, deliverables, and deadlines
Familiarity with JavaScript frameworks (jQuery, Telerik)
Test driven development experience using nUnit or Microsoft Test frameworks
Understanding of ORM technology (nHibernate, LINQ)
Experience with database design and modeling
Experience with SQL Server 2008 R2 is desired
Source management and development workflows using Microsoft Team Foundation Server (TFS)
Experience with Agile development methodologies with federal government software development projects
Excellent verbal, interpersonal and written communication skills
Strong analytical, problem-solving and decision making capabilities
Team player with the ability to work in a fast-paced environment
Resourceful and self-motivated
Ability to apply detailed knowledge of organizational procedures to make independent decisions and serve as a credible resource for a senior management team
Ability to work with all levels of internal staff, as well as outside clients and vendors
Superior interpersonal skills including courtesy, professionalism, and a cooperative attitude

212

Senior Analyst, Validation & QC Resume Examples & Samples

Set up and coordinate quality control activities related to oncology study database development and maintenance for EDC studies
Prepare specification documents, Plans, Test scripts, Summary reports for tools/applications
Conduct tester training and coordinate testing efforts in terms of quality and user acceptance
Manage study specific validation documents within Data Operations area
Responsible for the database and documents quality check for all EDCstudies
Strong knowledge of SDLC process
Experience in writing validation documents, e.g., Master Validation Plan, Requirement Specification documents, IQ/OQ plan, document & scripts, UAT Plan & scripts, Summary reports
Good understanding of standards: GCP, CFR Part 11, and related regulatory guidelines
Understanding of relational databases, e.g., ORACLE; Knowledge of the EDC System, InForm, SAS, and User interfaces for different EDC systems for clinical trials is a plus
Experience of handling multiple projects simultaneously
Strong communication skills: written and verbal
Able to work independently and a team player

213

Touch HW Validation Resume Examples & Samples

Key Qualifications
Mechanical background
Deep understanding and design experience in systems with Linear or Servo motors. Detailed knowledge in tolerance analysis, thermal expansions and material properties pertaining to high-precision xy stage and robotics design
SW background
Proficiency in programming and data acquisition scripting (C/C++, Matlab, LabView, Python, or shell)
Experience with programming embedded micro-controllers
HW background
Strong background and experience in EE, including precision analog and instrumentation (specifically in RLC and Linear circuits, Data conversion, time and frequency domains)
Experience with board design is a plus
Excellent critical analysis, statistical analysis, and logic/reasoning skills
Great written and verbal communication skills. Solid teamwork and leadership skills
At least 6+ years of relevant experience
Experience with Touch technology or other sensor technology is a plus
The ideal candidate comes from a Mechatronics background but has a strong hands-on experience in SW coding for user-facing automation. The candidate would have a deep understanding in control systems and experience with robotics or motor-based instrumentation

214

Head of AML Independent Validation Team Resume Examples & Samples

Formulating the governance, policies, standards procedures and templates as well as leading the execution strategy of independent validation
Leading and managing a team of statisticians and AML subject matter experts responsible for the effective challenge of end to end AML tools(including scenarios, ARS, CRS and segmentation) from both a technical and a functional perspective, including evaluating conceptual soundness, performance, and ongoing monitoring. Additionally, the centralized team will be supported by smaller regional teams across the Americas, and Asia
Accountability for ensuring the Independent Validation Team maintains independence from the Scenario Development & Enhancement Team and has appropriate incentives, competencies and influence to perform effective challenge
Ensuring that independent validations are consistent with appropriate standards and methodologies and review and approve validation results / key findings
Collaborating with and influence key partners (including developers, tool Sponsors, and senior management) to facilitate the validation process and resolve discussions / escalations of validation results in a timely manner
Challenging and enhancing the standards and methodologies to incorporate cutting edge industry thinking. Influencing the direction of the industry in the area of AML solutions
Representing the Independent Validation team in interactions with the regulators and Internal Audit
Recruiting, developing, and retaining high performing statisticians and AML subject matter experts
Optimize the efficiency of the independent validation process and manage capacity of the Independent Validation team; lead budget planning and financials
BA or equivalent experience. MS or /PhD in Statistics, Mathematics, Econometrics or other quantitative fields preferred
Minimum11+ years of relevant experience in large, complex environments
11+ years of experience managing a team of highly technical specialists with validating software in packages such as SAS, R, and SQL, other standard database query tools and related applications
11+plus years of strong model validation/data analytical skills, including data quality validation, descriptive statistics and predictive modeling experience
Demonstrated experience in successfully implementing projects in the financial services industry, preferably with Operations experience
Demonstrated experience in working across technology, compliance and business lines and managing inter-dependencies between different stakeholders
A significant degree of familiarity with AML and AML tools’ intended use
Knowledge of the local/regional laws and regulations applicable to anti-money laundering is a plus
Must have a strong background in statistical techniques (especially discriminant analysis, regression, decision trees) and methodologies (sampling approaches). Financial modeling of regulatory/risk analyses is advantageous, as well as awareness of modern techniques including machine learning and data analytics
Awareness of modern techniques including machine learning and data analytics

215

Power & Performance Validation Engineer Resume Examples & Samples

Mastering Emulation systems capabilities and support for power and performance, including emulating above OS real usages
System level understanding of power management flows at the hardware, firmware, and driver levels
In-depth level understanding of hardware power management such as P-states and C-states
Analysis of silicon power consumption versus pre-silicon expectations and drive resolution of issues towards higher battery life
Responsibility for SoC-level optimization under various usage scenarios
Contribute towards power management optimizations flows for future products
BSC degree in Computer Engineering (or Electrical Engineering with relevant SW courses)
2 years or more Coding experience (Assembly, Python, C++, C#)
Track record of practical problem solving and documentation skills
Excellent communication and/or interaction skills
Result oriented

216

Lead Validation Engineer Resume Examples & Samples

Bachelor’s degree in Electrical, or other engineering discipline
3 years experience in Engineer or related field
ELIGIBILITY REQUIREMENTS
Wind related experience
Demonstrated ability to manage projects and people/contractors
Hands on skills for using test equipment both electrical and mechanical

217

IP Validation Engineer Resume Examples & Samples

Proficiency in OVM, UVM or VMM methodologies
Experience in verifying complex, multi-clock and multi-power domain designs
An ability to lead & collaborate with a diverse team in a dynamic work environment
A love of problem solving and the motivation to stress test design with the goal of finding all possible design bugs
Validation Experience with computer architecture design, deep/machine learning, DSPs, caches, memory controller
Protocol knowledge in I/O specifications such as IOSF, PCI, AXI, AHB, OCP, PIF

218

Hardware Validation Engineer Resume Examples & Samples

0 - 1 + years of overall experience in validation/test experience
Experience with MatLab
Experience with EE fundamentals
Experience with PMIC archeitcture, power supplies, LDO, DC-DC switches, common I2C/SPI/UART busses, and electrical signal characterization
Strong scripting experience (i.e. Shell, Perl, Python, etc.)

219

Associate Ccar Risk Process Validation Resume Examples & Samples

Perform independent validations of select CCAR Risk processes, including interpretation of FRB and Basel relevant regulations and implementation thereof
Four to six years of financial services experience
Strong risk, process and control validation/testing and/or assessment skills. A prior role within consulting or internal audit covering risk processes is preferable
An undergraduate degree (B.A., B.S., or equivalent) required

220

Software Verification & Validation Expert Resume Examples & Samples

Ensure compliance of V & V process, activities and records and be accountable in front of third party audits and inspections and enforce implementation of good quality practices (documentation, traceability, record, inspection readiness) within V & V organization
Share and implement best practices coming from other global function, industry and benchmark
Support change control processes in support of system changes. Provide change control training as requested
Manage a Team of Contractors in Verification & Validation : budget, purchase orders, follow-up with their companies, project assignment
Bachelor’s Degree or equivalent in a life science or engineering discipline with > 8-year work experience as a V&V Engineer in the Health Care related industry
Experience in the management of regulatory audits (i.e. FDA, ISO,…) and expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, GAMP5, 21CFR11, Computer System Validation, etc.)
Significant experience with validation and verification techniques and methodologies
Experience in team management
Excellent interpersonal and communication skills and good problem solving skills enabling the individual to establish a high level of credibility to positively influence activities
Personal qualities of enthusiasm, determination, patience and leadership are required to influence the outcomes of stakeholders such as senior management, customer, colleagues
Scope and Resources Accountability: Global projects/Global project lead
Financial Indicators (revenue, budget, etc.): Successful delivery of verification and validation tasks within project timelines and budgets
Key Performance Indicators (KPIs): Conformity with standards and procedures
Key Contacts (internal / external) and Interfaces: Project Teams, Manufacturing Sites and Subsidiaries, Engineering Experts, IS Experts, Quality Leaders, Quality Experts

221

Operational Risk & CRD IV Process Validation Resume Examples & Samples

Perform independent validations of select FRM processes, including interpretation of Basel relevant regulations and implementation
Day to day oversight and management of the Operational Risk (incl. CCAR) and CRV IV Validation book of work, including the potential to manage a small team across three Global locations
Bachelor’s degree or equivalent, ideally in a quantitative discipline, Finance, Economics or similar
Extensive work experience in operational risk/control based roles within a financial services environment
Strong technical understanding of the financial services regulatory environment, with a focus on Basel and CCAR principles and specifically Operational Risk practices
Strong risk, process and control validation and/or assessment skills
An audit background or report writing experience would be preferable

222

Validation Architect Resume Examples & Samples

Setting end to end validation strategies and methodologies at silicon and platform level
Defining requirements to enable world-class validation content
Consulting architecture teams on validation impacts, DFx hook definition, etc
Making regular report outs to program-level forums such Mission Control
Providing quantitative as well as qualitative input to all tape-in and tape-out decisions
Driving continuous improvement via bug/coverage analysis, arch reviews, customer interactions
Engaging as necessary on critical debug and firefighting efforts from pre-silicon to launch
Collaborating with business units on Validation, Quality, TTM initiatives
Developing and strengthening technical leaders across the organization
Ensuring consistency, reuse and teamwork across server teams

223

Director, Computer System Validation Resume Examples & Samples

Lead and coordinate internal / external resources to ensure the flawless execution of multiple critical GXP projects and support ongoing needs of production systems
Assist in the definition of project validation and SQA scope and objectives, involving all relevant stakeholders and ensuring feasibility
Ensure that the planning and execution of initiatives are delivered on time and within budget
Develop and manage a team of subject matter experts responsible for assuring that validation deliverables for cGxP computerized systems meet the requirements of US and International regulatory agencies
Review and approve documentation and provide guidance to site staff on cGxP requirements for CSV with hands on ability
Collaborate with QA, IT, business functions and GxP-regulated vendors to ensure successful planning, execution and delivery of validation projects
Perform quality review of validation documents in accordance with applicable regulations/guidance, ICH guidelines, standard operating procedures (SOPs) and industry standards
A hands-on leader with ability to lead teams, and be accountable for validation and change control activities
Conduct vendor audits and associated activities for GxP-regulated systems
Conduct periodic system reviews of GxP-regulated systems
Contribute to the improvement of CSV methods, using compliant, efficient, and risk-based approaches
Collaborate with stakeholders and contractors to manage the lifecycle of computerized systems and their associated documents
Enforce computer validation policies, processes, and practices
Revise SOPs and Quality Technical Agreements as required
Establish timeline and process to ensure Medical Affairs annual and long-range planning are efficient; manage team to deliverables
Ensure all GXP systems internal/external adherence to regulatory / industry / corporate / department / function regulations, policies, and procedures
Act as ambassador for IT function across entire organization
Inspire and drive the IT team to collectively meet or exceed agreed-upon levels of performance
Create a positive, performance-based culture within IT that is built on trust, and aligns with the overall Intarcia culture
Bachelor’s degree, Relevant Certifications desirable
6+ years’ experience in a cGxP regulated environment in a management / lead role, with exhibited knowledge or proficiency of life sciences industry regulatory standards for computer system design, implementation, and validation
Demonstrated ability to manage and motivate direct reports and contractors
In depth knowledge of pharmaceutical regulations including 21 CFR Part 11, GMPs, GCPs, GLPs, GAMP 5, and Annex 11
Ability to comprehend technical information related to computer software (operating systems, software applications), computer and network hardware, and the associated regulatory expectations relating to them
Experience and proficiency with industry standard enterprise system applications (LIMS, SQL, MES, eDMS, ERP, CMMS, eQMS, CTMS)
Proven track record for successful validation of ERP/MRP systems
Experience in managing multiple validation projects, developing plans, managing to project schedules and directing internal and vendor/contract resources in creating CSV deliverables
Experience validating GxP-regulated applications for quality management, regulatory submissions, controlled document management, biostats and data management solutions, clinical development, learning management, lab management, and ERP
Must possess excellent communication, conflict resolutions, influence and problem-solving skills
Understanding of the validation methodologies applied to on-prem applications and hosted environments, SaaS and cloud
Strong attention to detail, quality oriented
Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment
You have successfully managed multiple projects, large and small, at one time
Your teams have gone through internal or external audits and passed with flying colors
You have a proven ability to deliver on goals in a collaborative way
You are obsessed with making a meaningful difference in the lives of people living with serious chronic diseases like diabetes
You have superb communication and interpersonal skills along with ability to influence others
You have a strong attention to detail combined with a simultaneous ability to always see the “big picture”
You visibly uphold impeccable ethics and unquestionable integrity in all that you do
You can translate concepts and ideas into timely action and high-impact results
You have the demonstrated ability to work with multiple internal cross-functional teams and successfully manage multiple projects simultaneously
You are able to communicate complex information and concepts succinctly and with impact
You bring high energy, a collaborative spirit, and an entrepreneurial mindset
You have shown the ability to thrive in a small but rapidly growing and changing organization; you are comfortable with ambiguity and uncertainty
You are unwilling to settle for anything less than excellence in yourself and your team

224

Powertrain Validation Engineer Resume Examples & Samples

Serves as the Senior Powertrain Validation Engineer subject matter expert for PACCAR Powertrain Validation Summer & Winter vehicle testing with a strong focus on the Engine Aftertreatment System and Engine Cooling packages providing insight, development, and tracking of all related validation procedures and status
Ensures Powertrain Validation Summer and Winter testing is executed on time, within budget and the full scope of testing programed is completed and reported accurately
Anticipates challenges and ensures timely and effective options are implemented
Leads additional PACCAR Technical Center environmental testing projects, which can cover a wide scope of engineering disciplines as required
Oversees all Summer and Winter test data collection and analysis
Writes reports as appropriate, incorporating results, conclusions, and recommendations

225

Global Validation & Statistical Operations Process Resume Examples & Samples

Supporting global strategic initiatives through the enablement function; planning and leading the realization of these plans
Define and develop frameworks to leverage capabilities from across the world, in order to drive greater global consistency. This person will interface with the Regional execution teams working together to drive quality and improve client delivery
Act globally as enablement specialist regarding any activity linked to Input Validation and Statistical Operations; this includes supporting the regions on key initiatives/BAU challenges, and driving change through sharing of expertise. Focus areas can range from driving Panel Management improvements, to Product Enhancement support, to Raw Data validation improvements, to analysis and recommendations on quality challenges
Support the Validation and Statistical Operations Quality agenda as well as process harmonization activities both within and across the platforms in close collaboration with Execution teams. This team is also responsible for establishment of in-process metrics; SOP documentation, training and certification maintenance; compliance tracking; and platforms enhancement management. This team will also work closely with other functional enablement teams and COEs including Data Science and DA
Maintain two-way communication process with other Pillar Enablement Executives, RD/Output/DA/Data Science Methods/Data Science SAGE – ensuring strict alignment and coherence
Work closely with BPI organization as and when required
Work closely with Performance Metrics team, engaging and supporting on generation of quality health reports and RCA's. This includes risks and opportunities and translating these initiatives into enablement strategies/ plans as well as leading the execution of these plans - engaging all global/regional/local resources as appropriate
Actively support Quality and Productivity targets by leveraging solutions and learnings across regions/countries/platforms
Review of KPIs for in process management at country level, regional & Global level as well as specific KPI linked to Workload drivers, and usage of these KPIs to drive subsequent action plans
Supporting key strategic initiatives, driving resource plans, engaging with the regions, removing roadblocks where necessary, and being point of contact for report outs/escalations to senior management
Play a leading role in developing and mentoring high performance execution individuals capable of assuming roles of increasing responsibility within and across the organization
Expert support to include Product Enhancements, Panel Management, Rawdata Validation Support, Factory SME knowledge. Knowledge to be shared during development of various levels of SME experts (inside/outside platform) through on-going training and special projects

226

Director / Associate Director, Validation Resume Examples & Samples

Author and review SOPs, protocols, reports and Validation Master Plans for GMP equipment, instruments, and computerized systems. In some cases also execute approved protocols and generate final reports
Develop and implement validation policies and related procedures based on current regulations and industry standards in support of the company's growth and regulatory requirements
Assist end users in developing User Requirements Specifications and SOPs for GMP systems
Train end users on validation policies and requirements to support cGMPs
Generate and keep current inventory of all GMP systems and requalification/revalidation schedules
Evaluate all GMP systems for Risk Assessment using FMEA approach. Plan validation efforts according to risk
Implement, track, and maintain group budget
Manage validation team members, projects and timelines. Track department metrics and provide monthly progress reports to Head of Department. Coordinate multiple projects and shifting priorities
Mentor, coach, train and evaluate a team of junior and senior validation engineers. Lead hiring efforts for team growth and attrition
Effectively interact and collaborate with cross-functional departments in order to meet company expectations
Collaborate with clients and vendors to meet project and company objectives
Serve as subject matter expert in all aspects of validation
Support internal, client and regulatory audits and inspections. Oversee all gaps identified during these events
Troubleshoot and coordinate failure investigations for manufacturing and laboratory equipment. Assist with vendor communications and maintenance/repair scheduling
Investigate and implement continuous improvement projects in support of company activities and growth

227

Device Validation Manufacturing DVM Resume Examples & Samples

Candidate should possess an Engineering degree in Electronics Engineering or Bachelor/Master of Science degree or Computer Science or Computer Engineering degree
Experiences in C, C++ programming skills
Some experience with scripting languages such as Python or Perl shall be an added advantage
Some basic experience with firmware development environments including compilers, debuggers, emulators, and tool chains
Experience with hardware/software debugging using oscilloscope, logic analyzers and/or protocol analyzers
Understanding of data manipulation and memory-management algorithms
Some understanding of Power Management (S-states, C-states, P-states) and Controls may be added advantage
Some understanding of Industry standard Interface protocols (SATA, USB or PCIe)

228

Systems Validation Engineer Resume Examples & Samples

The successful candidate will have a 4-year degree in Electrical Engineering, Software Engineering, Computer Science or related field
Five (5) years of directly related experience in systems testing and validation
Strong knowledge in several testing methodologies
Experience in Python, C/C++ or similar programming languages with an ability to build tools and write scripts for testing
Experience with Application Programming Interface (API) testing
Proven analysis and problem solving skills and abilities
Strong internal customer and external client-facing skills
Previous testing and validation experience with Bluetooth, Wi-Fi, embedded software, or IoT products and technologies
Previous experience in a fast paced, deadline driven environment
Experience working in a collaborative environment with Electrical, Mechanical & Software Engineers, and Project Managers

229

Senior PM Validation Resume Examples & Samples

Be proactive in developing proposals as a result of leads, potential sales opportunities, and RFPs/RFQs as required
Maintain communication with key client contacts locally in order to identify client needs and repeat business
As time permits, actively participate in local chapters of professional societies (e.g. ISPE, PDA)
Responsibility for all assigned proposal follow up - maintain a current listing of pending proposals with status
Prefer experience with biopharmaceutical, pharmaceutical, medical device, and/or food & beverage sectors
The candidate should have at least 10-15 years of relevant experience
Negotiating skills, presentation skills, commercial skills and long-term relationship building are all competencies which need to be well developed for this role
Must have the communication skills necessary to effectively communicate with co-workers
Must be skilled in the Microsoft Office Package; Word, Excel, Project
Position demands an individual who has good time management skills that can handle multiple tasks and deadlines in a fast paced environment

230

Hardware Validation Engineer Resume Examples & Samples

Specific Knowledge, Expertise, Coursework
Knowledge of audio components: speakers, amplifiers, head-units etc…, how they are designed, work, and interact with each other
Competent computer skills, including Microsoft Word, Excel, Powerpoint, and Outlook
Certifications/Licenses
Green Belt/ Black Belt is a plus
Specific Prior Experiences
5 years related electrical engineering experience
Prior experience with audio components: speakers, amplifiers, head-units preferred but not required
Prior experience working with a team of technicians

231

Memory Validation Engineer Resume Examples & Samples

Bachelor's of Science in Electrical Engineering or equivalent work experience
Experience in DDR/LPDDR, and HSS200/400 characterization and qualification/validation
Experience in defining and writing diagnostic code
Experience with memory operations at interface and protocol level
Experience in creating stress conditions for various modes of operations
Experience with memory controller design
Experience with hardware and software debugging
Experience with High Bandwidth scope, TDR and VNA measurement equipment
Understanding of Signal/Power Integrity and PCB CAD software
Strong knowledgeable of PCB/Package layout principle
Understanding of high-speed signal interface standards such as DDR2/3/4, USB2/3, DP, HDMI, SATA, PCIe, etc
Work experience with in DRAM industry is a big plus
Excellent communication skills and teamwork abilities

232

Software Verification & Validation Engineers Resume Examples & Samples

Test software for highly complex medical devices/instrumentation
Work with electronic testing equipment
Apply experience with black box testing to plan, write test cases, test reports, and test software and hardware requirements for a Class II Medical Device
Write technical test protocols and technical reports
IVD Product Development and IVD Product Testing
Perform software Verification and Validation testing in an FDA/UL regulated environment
Assist with all aspects of medical device life cycle process, IEC 62304
Troubleshoot product problems, improvements or field complaints
Apply evaluation methods in the design, development and debugging of SW programs
Support Regulatory Affairs for 510(k)
Perform laboratory work to assure completion in accordance with established safety procedures and applicable regulatory regulations
Develop instructions and documentation for manuals, V&V plans and acceptance criteria documents
Ensure software validation procedures and guidelines are maintained and kept current with FDA guidelines
Review SOPs for regulatory compliance
Assist with creation of Tools validation protocols
Mentor junior team members in daily tasks, providing feedback as needed

233

Specialist, Quality Validation Resume Examples & Samples

Under general supervision ensures cleaning and manufacturing processes are validated to required standards. Also provide QA oversight to E&T and ensure equipment/systems remain in a validated state. Administers troubleshooting efforts for protocol discrepancies. Investigates common deviations associated with failures in cleaning or process validations. Applies theory, technical principles, and judgment to address a broad range of difficult projects/problems and reviews complex deviations to management for resolution
Responsible for developing validation moderate protocols under supervision using a risk-based approach that meets current regulatory requirements and industry practices
Presents the validation approach and protocol results to peers and management as required. Assists or interacts with regulatory agencies as necessary
Reviews and interprets data for accuracy of cleaning/process performance for completed validations/re-validations, and prepares report packages by analyzing and summarizing the data to support test and protocol requirements
Successfully manages small to medium cross functional projects to ensure deliverables are met on time
Reviews and approves controlled documents relating to processes, cleaning, equipment, and computer systems validations
Quality assurance oversight (as applicable)
Works under general supervision to provide quality assurance oversight of commissioning and qualification activities for adhering to compliance with cGMP’s, regulatory, industry, and corporate requirements. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, providing concurrence on protocol discrepancies, providing quality approval of impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet all requirements. Ensures Quality decisions are made, with consultation from Quality colleagues and management, which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas

234

Product Engineering Silicon Validation Resume Examples & Samples

1) Candidate must undertaking B.Eng in Electrical / Electronisc Engineering or equivalent
2) Solid understanding of digital and analog circuits
3) Exposure to Quartus II and Development Kit is an advantage

235

Validation Consultant Resume Examples & Samples

Technical degree or equivalent with at least 10 years experience with focus on the life-science industry and a proven track record
Proven experience with IT Quality Management and Computerized Systems Validation (GMP, 21CFR Part 11, GAMP) together with PCS/MES application implementation and deployment in the regulated pharmaceutical industry including awareness of customers’ responsibilities
Good knowledge of European and International major pharmaceutical regulatory requirements (FDA, EMEA, ICH)
Trained in ISO 9001 with auditor training and relevant experience
Ability to influence the culture of a project team or department to adopt and maintain good quality standards
Experience in Quality Management and Quality Systems development
Proven experience and personal credibility in front of customers and colleagues is essential
Basic knowledge of project management. Ability to deliver training
Member of ISPE, with involvement in Communities of Practice to ensure current knowledge
A high level of customer interfacing skills
Proactive and able to work effectively within a remote team
Fluent English (written and spoken) with additional languages preferred

236

Senior System Validation Engineer Resume Examples & Samples

Knowledge of WI-FI protocols preferred. Ability to troubleshoot as needed to solve problems. Problem reporting should include a full analysis of test scenario used and the issue found
The candidate should be very familiar with the use of test tools and be able to analyze traces and isolate problems from the information gathered in the traces
Understanding of application processor technology is a plus
Experience in scripting using TCL, Expect, Python & Perl will be considered

237

Silicon Validation Full Stack Web Developer Resume Examples & Samples

Web/Scripting: HTML, CSS, JavaScript, Ruby, Python, Perl
Data modeling and storage: Relational databases (MySQL, PostgreSQL), document stores (MongoDB, CouchDB)
Distributed systems, data aggregation and analysis
Data structures, algorithms
Independently driven, proactive, accountable, reliable, team player
Additional desirable qualifications
Scripting: Tcl/Expect, Bash
Ruby web stack (RVM, Bundler, Capistrano, Sinatra, Sprockets)
RPC and message queues (RabbitMQ)
Centralized configuration management, eg Puppet, Ansible, Chef, or Salt

238

Team Leader Validation Group Resume Examples & Samples

Ensure validations are within compliance by following industry standards, corporate policy, and regulatory requirement
Write and/or revise SOPs, and maintain all validation related documentation
Develop validation master plans, process flow diagrams, test cases, or standard operating procedures
Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols
Informs management of issues identified during qualification and validation activities. Recommends appropriate actions to address the issues
Participation and support in expanding of PPI Business (lean management) System and related activities within the biomarker´s unit with a focus on process efficiency, quality and customer satisfaction
Perform validation monitoring of indicators for Biomarker and make proposals to implement actions necessary to improve them
Background as Engineer, Master in biotechnology / Biochemistry is preferred
Sound experience in industry (IVD or pharmacy) especially in qualifying of equipment and validation of processes
Strong regulatory knowledge in validation / qualification
Knowledge in industrial processes: CAPA, ISO 13485, CFR part 820
Leadership skills paired with analytical ability and solution-oriented approach
Customer focus oriented
Bilingual German / English a must, French would be a great asset

239

System Solution Validation Intern Resume Examples & Samples

Validation requirements, methodology and test plan
Execute and deliver per the project milestones
Work with relevant project stakeholders to resolve problems

240

Director, Standards & Process Validation Resume Examples & Samples

In conjunction with HCA leaders, contributes to the development and execution of care management strategies that support HCA
Comply with Corporate Regulatory and Compliance Department to ensure HCA Corporate practices and policies regarding utilization review meet state and federal regulatory requirements
Develop and implement effective examination and verification processes and tools to provide ongoing assessment of facility practices and industry changes to ensure enterprise remains current in Case Management processes related to, but not limited to, Utilization Review and regulatory directives
Develops, establishes, and maintains effective and positive relationships within the department and with HCA clinically related departments as indicated to promote and ensure success of Case Management goals
Remains current in knowledge and understanding of governmental, CMS and The Joint Commission regulations
Ensures case management strategies are implemented and adhered to across the organization. Presents strategic recommendations to case management leadership based on internal and external drivers and trends, supports strategic initiatives, and effectively manages and completes strategic objectives and department priorities
Daily responsibility to ensure work plans remain on track and deliver planned results
Works directly with CM Analytics & Technology teams to ensure consistent processes and standards are supported in defined tools and reports
Enables decision-making by effectively analyzing business drivers and constraints, and presents alternative solutions to address problems and opportunities
Develops new tools and processes related to the compliance to government standards and regulations
Actively participates in advancing and maturing the teams' capabilities, ensuring continuous improvement
Develops a culture of high performance and continuous improvement that values learning and a commitment to quality
Communicates timely and effectively in a matrix environment
Escalates issues to leadership as necessary
Demonstrates strong leadership skills including: proactive decision-making skills, negotiation skills, consensus building ability, effective communication skills and team-building abilities
Demonstrates strong management skills including: ability to prioritize, completes work on time, resources efforts appropriately, manages work assignments and team approach
RN with current state licensure
Strong clinical background with 7 years acute care nursing experience
Minimum of 5 years case management experience
Previous management experience, at or above the facility level preferred
Knowledge and understanding of governmental, CMS, and JCAHO regulations
Knowledge of audit and process improvement processes and practices
In-depth knowledge of case management, discharge planning, medical necessity criteria and utilization review practices and ability to incorporate successful current trends
Significant experience in designing and leading initiatives with proven performance in meeting strategic, financial, and client satisfaction goals on deadline
Ability to communicate effectively in oral, written and electronic formats
Ability to establish and maintain collaborative and effective working relationships with a focus on the importance of teamwork
Demonstrates leadership skills which model analytical and critical thinking abilities, problem resolution, proactive decision-making, negotiation skills, consensus building, and effective resource utilization

241

Validation Engineering Specialist Resume Examples & Samples

Bachelor's Degree in Mechanical, Civil, Aerospace or Electrical Engineering from an accredited college or university (or a High School Diploma / GED with a minimum of 5 years of Wind Turbine or Services Engineering experience)
Minimum of 1 year of experience in Services Engineering
Knowledge of Process Validation, Statistical Analysis, Technical Documentation, Engineering Standards, or Guidelines
Proven ability to work under pressure and challenging conditions
Ability to work effectively in a matrix environment with a global team across cultural boundaries

242

Validation Associate Resume Examples & Samples

Maintenance of on-going sterilization process validations. To include preparation of validation protocols and reports, execution and/or oversight of validation activities, and product bioburden monitoring
Review sterilization related nonconforming product reports (NCMR) and disposition nonconforming material
Initiate, investigate and implement corrective and preventive actions as required
Lead product/ process risk assessment teams. Perform periodic review and update of existing risk assessments
Monitor applicable sterilization standards for updates and ensure internal documentation is compliant to all requirements
Participate on product development teams to develop, validate and implement appropriate sterilization processes for new products
Internal audits
Experience with biological products and/ or chemical processing highly desirable
Working knowledge of GMP and ISO 13485 requirements. Working knowledge of ISO 17665, 11135 and 11137
Knowledge of other sterilization methods highly desirable
Strong problem solving, technical writing and organizational skills
Knowledge of basic statistics and basic quality tools
Previous experience with product/ process risk analysis and NCR/CAPA
Working knowledge of MS Word, Excel, and Outlook applications
ASQ Certification in Quality Engineering is desirable
Previous auditing experience is desirable
Minimum of a BA/BS in engineering, biological science or related field of science
Experience in Medical Device Manufacturing required with 3-5 years of sterilization validation experience

243

Specialist, Computer Systems Validation Resume Examples & Samples

Reviewing of Atlas SAP (the Animal Health ERP system) validated documentation
Administration of Change Control Process via Remedy
Administration of Document Management system
Authoring and Reviewing of Standard Operating Procedures
3-5 years relevant work experience with Validation or Compliance
1-3 years Experience in a GxP Validated environment
Organized, Accurate and Efficient documentation skills
A team player who places great emphasis on collective achievements and team diversity

244

Powertrain Validation Engineer Resume Examples & Samples

Serves as a Powertrain Validation Engineer and subject matter expert providing insight, research, planning, execution, and tracking of all assigned validation testing and projects
Conducts actual hands-on truck vehicle validation testing
Plans, coordinates, and conducts projects and tests of moderate scope with minimal supervision
Analyzes project requests, reviews project requirements with requestors and formulates preliminary project plans, budgets, and schedules
Orchestrates all assigned data collection, analysis, and testing
Designs required fixtures and specifies instrumentation, equipment, vehicles, loading configurations, software versions, and data processing techniques
Leads the setup of tests, verifies that test equipment and instrumentation equipment meets specified requirements and performs software and data checks
Coordinates with associated DAF, Division, and PACCAR Test Center (PTC) engineers to ensure content accuracy and completeness of assigned testing and projects
Presents results of test or projects to divisions or management personnel
Develops and maintains a high level of familiarity with PACCAR products and service tools
Minimum 6 months of truck/automotive related work experience desired
Experience with vehicle software highly desired
Ability to manage personal workload and willingness, flexibility and initiative to respond to shifting time and project demands
Powertrain hardware and software testing experience a plus

245

Lims Validation Coordinator Resume Examples & Samples

Preparation of protocols and test scripts, and checking once executed
Validation oversight and deviation management
Checking static data load
Applicants must have relevant experience with LIMS and computer systems validation, preferably in the Pharmaceutical industry
Experience in implementing validation policies and procedures
They must bring a structured approach to project work, and the ability to work productively as an independent member of a small, geographically dispersed, team
11 December 2016

246

Claims Validation Administrator Resume Examples & Samples

Daily validation of distributor claims errors while utilizing the SAP IP contract management system
Maintain monthly chargeback/validation process with distribution partners. This includes generating monthly claim validation error reports and working with each of our distributors to validate errors and/or receive reimbursement. This position will be responsible for improvement processes to streamline distributor errors and become proactive in errors as they are identified verses in monthly reporting
Work with distributors throughout claim resubmissions and ensure they are loaded correctly in SAP while communicating status of resubmissions with the finance team to assist in validating the clearing of distributor deductions
Working closely with distribution partners to communicate problems/issues as they arise. This role will also work closely with the contract administration team regarding contract communications as they relate to rebate errors and denials
Work closely with the finance teams to assist in the monthly reconciliation of the rebate deductions and collection efforts. This includes validating appropriate charges and ensuring promotional activity is not included in rebate expense
Associates Degree in business or accounting and three to five years’ experience in data analysis or accounting
Experience with Microsoft Excel, Microsoft Access and Microsoft Word are required with a demonstrated ability to export and analyze data in Excel using filters and pivot tables
Superior verbal and written communication along with the utmost professionalism and customer service
Experience with SAP or other similar systems/transaction based software
A sense of urgency and demonstrated commitment to meet deadlines. This role requires an individual to be detailed oriented, organized, work well under pressure and able to handle multiple and competing tasks to meet deadlines in a collaborative, collegial manner

247

Development & Validation Engineer Resume Examples & Samples

Execution of LADV plans for development and validation of hybrid control systems
Conducting peer reviews for test plans
Providing validation input to the PDTs/TRBs
Support development and testing of new vehicle features/functions
Writing and updating GMW test procedures and related CG
Supporting development vehicle fleet with troubleshooting and data collection
Support integration vehicle, ManVal, and production builds at PPO and assembly facilities
Update development, durability, and crashworthiness vehicle with new VeSCoM release software
Support for durability and crashworthiness teams with hybrid controls
Define root cause of issues found during development and validation testing
Utilize Problem Resolution Tracking System (PRTS)
Coordinate test plans with other test engineers
Conduct and participate in verification and development trips
Documentation of all test processes and issue engineering reports
Plan and implement complex test and/or development activities
Evaluate engineering changes and there effect on validation test plans
Actively participate in and report out to the program teams
Ensure electrification system integration meets customer expectation

248

Validation Associate Resume Examples & Samples

Prepare, review and approve validation, hold, investigation and audit reports; gain multidisciplinary consensus; make recommendations to management based on review and analysis of data
Manage, schedule, execute and track multiple project activities of moderate complexity with multi-disciplinary departments to ensure timely completion of deliverables
Analyze data to determine trends, acceptability, identify deviations and assure resolution of deviations
Conduct deviation investigations, such as validation failures, complaints and hold investigations. Identify appropriate corrective actions
Assess impact of changes in systems, critical documentation, processes and suppliers
Identify critical parameters/processes and takes appropriate actions to ensure adequate controls are in place
Interact during client and regulatory audits
Lead audits and/or assist with regulatory audits
Provide training in area of expertise within Validation
It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace

249

Senior Validation Associate Resume Examples & Samples

Prepare, review and approve production, validation, audit reports and/or master batch record documents, procedures, and rationales
Manage, lead, schedule, execute and track multiple projects of high complexity with multi-disciplinary departments to ensure timely completion of deliverables
Serve as principle/validation liaison for negotiating with clients on agreements/projects and resolution of significant validation, product and regulatory issues. Coordinate, review and prepare customer audit responses and reports
Evaluate new regulations, changes to existing regulations and regulatory trends; perform gap analysis to determine deficiencies and take appropriate actions
Establish actions and implement systems to achieve process improvements and efficiencies to address shortcomings in processes and systems
Serve as principle in hosting and coordinating regulatory inspections performed by the FDA, MCA and other regulatory agencies. Coordinate, review and prepare regulatory audit responses and reports
Defend policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits
Establish and supervise quality programs and plans (e.g. validation, QAT, supplier certification)
Identify training needs and develop training programs

250

Lead Validation Engineer Resume Examples & Samples

Bachelor’s Degree in a Science or Engineering discipline with 5-8 years relevant experience
Experience using Val-genesis Software a plus
Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment
Must be (or quickly become) familiar with the relevant areas of science (some indicated in table below) applicable in area(s) of deployment
Must be (or quickly become) familiar with the general areas of Technical knowledge / understanding indicated in table below
Ability to objectively review
Ability to make judgments in the wider context of quality/compliance
Ability to perform effective trouble shooting
Ability to command technical authority on specific projects

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