Validation Engineer Resume Samples

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O Cormier

Oswaldo

Cormier

943 Kub Dam

San Francisco

+1 (555) 899 7299

943 Kub Dam

San Francisco

Phone

p +1 (555) 899 7299

Experience Experience

Los Angeles, CA

Validation Engineer

Los Angeles, CA

McKenzie-Fay

Los Angeles, CA

Validation Engineer

Develop and perform engineering studies for improvements of equipment performance or process capabilities to reduce costs and cycles with ensuring validations
Develop and perform engineering studies for improvement of equipment performance or process capabilities to reduce costs and cycles with ensuring validations
Create and manage Validation Test Plans including Analysis/Development/Validation Plan and Report Form (ADVP&R)
Improve workmethods by analyzing methods and procedures to ascertain the most efficient wayto perform all tasks
Work closely with Engineering to develop, coordinate and execute Validation documents and strategies
Provide manufacturing quality engineering support for current business to improve quality through improved manufacturing processes and process control
Identifying opportunities to revise and improve product design or product performance and implementing these improvements

Detroit, MI

System Validation Engineer

Detroit, MI

Aufderhar, Heidenreich and Hermann

Detroit, MI

System Validation Engineer

Interface with management to provide regular reports
Responsible for the development/enabling/execution/tuning of complex workloads for different server segments
Provide reports on the health of the product/device from a systems point of view
Analyzes & understands the validation & debug processes, drives new/better/best methods, improves our capabilities and efficiency
Planning, developing and executing validation tasks
Developing a verification testing process that validates the testing at all levels of the organization
Designing, developing and debugging Validation Tools and SW

present

Houston, TX

Senior Validation Engineer

Houston, TX

Treutel and Sons

present

Houston, TX

Senior Validation Engineer

present

Applies basic to moderate Risk Management principles to work
Lead execution of all aseptic and process validation functions and provide guidance and assistance regarding execution to validation engineers and technicians
Drive continuous improvement throughout the development process
Create a test plan to make sure that the component/ ECU/ Subsystem/system can be verified for all the functionalities
Perform other duties as assigned by the Sr. Manager, Quality Systems
May participate on process improvement teams to develop guidance and procedures pertaining to validation
Authors and/or contributes to the development and implementation of Vertex Policies, SOPs, Work Instructions, Forms, and Templates surrounding validation

Education Education

Bachelor’s Degree in Engineering

University of Pittsburgh

Bachelor’s Degree in Engineering

Skills Skills

Good interpersonal skills and the ability to work in a highly cooperative team environment across many time zones are also desirable
Knowledge of aseptic processing and terminal sterilization is highly desired. Knowledge of cGMP regulations and latest validation guidelines essential
A proactive self-starter with motivation to provide strong deliverable quality and a positive Customer experience
Should be able to work in a challenging and engaging work environment that promotes teamwork, creativity, accountability and professional development
Detailed knowledge of quality management systems
We are looking for someone with a strong technical background, with a very good analytical mind, problem solving skills, autonomous, able and willing to learn
You will set-up the test environment: Accountable for quality deliverables; running tests from end-to-end
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) highly desired
Knowledge in python scripting. Comfortable with Automation frameworks, Manual testing
Knowledge in iDrac testing, AXON framework, Linux scripting knowledge

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15 Validation Engineer resume templates

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Analog Validation Engineer Resume Examples & Samples

Responsible to set standards for the evaluation and validation environment in the company and lead the staff towards successful execution
Keep up to date with all the advances in the field and ensure the company is well at the forefront of the state of the art technology, methodologies and processes used in the industry
Gather creative and talented technical staff and form a team for achievement of targets
Working with both Analog and Digital design managers ensure the comprehensive validation of the product and the information is provided to help improve design and modified as necessary based on the requirement of the customers
Ensure comprehensive and timely delivery of all deliverables including software drivers and embedded DSP code as required by the customer to adopt the company solution
Familiar with the state of the art SoC validation process and methodologies
Hands-on knowledge of board level design for customer demonstration and evaluation
Solid knowledge of power/ground, interference, and noise consideration in board level design
Know-how and expertise in board level design and requirements for mobile and other consumer electronics products
Familiar with the overall consumer electronics products including necessary software
Knowledge of evaluation and validation methodologies to be able to mentor design engineers at all levels
Excellent leadership skills and ability to manage multiple subcontracts to deliver consistent overall solution
Excellent organization skills and ability to manage time well
5 to 10 years of professional experience in circuit design or relevant technical field
Equivalent of B.S. Engineering Degree (Master's degree preferred)

Quality Validation Engineer Resume Examples & Samples

The successful candidate will be an energetic individual, well organized, able to multitask and balance conflicting priorities, self-motivated with the ability to work with cross-functional teams and motivate others
The successful candidate should have primary degree in Quality Management, Engineering, or Science, with a minimum of 3 years validation experience in medical device/pharmaceutical/diagnostics experience
Strong, structured problem solving ability, 6 sigma and experience in a medical device assembly environment would be a distinct advantage

Validation Engineer Resume Examples & Samples

Responsible for ensuring conformance with current equipment, process, and systems validation regulations
Responsible for determining the implications of validations upon; Product Quality, Patient Safety, and Data Integrity
Responsible for completing gauge R&R qualifications
Participate in Worldwide equipment, process, and software development
Responsible for determining and implementing control measures to reduce the occurrence and possible impact of failures
Responsible for determining process inputs and factors for variation where process capability is required
Responsible for calculating process capability
Maintain complete and accurate documentary evidence concerning Qualification and Validation exercises
Responsible for communicating and obtaining input/acceptance of stated exercises by relevant departmental personnel
Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s
Responsible for validation activities for NPI's / product transfers
Responsible for Quality Engineering responsibilities of NPI's / product transfers
Responsible for process and equipment risk management pFMEA / RA
Responsible for implementing/validating new technologies
Contribute towards company procedures regarding validations
Responsible for conducting periodic review activities concerning the above
Ensure HSE is included on all Quality change order procedure

Senior Quality Validation Engineer Resume Examples & Samples

Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
Runs /Manages complaint investigation and resolution of same
Designs and develops validation documentation to support business continuity, new process introductions
Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation

Quality Validation Engineer Resume Examples & Samples

BS in a related science or engineering field
Minimum of 5 years experience in PA Quality Assurance that manufactures OTC products
Must have equipment utilities experience in batch manufacturing in cGMP environment, protocol development and execution, performance of validation assessments and development of validation plans
Excellent organization and prioritization skills

Component Validation Engineer Resume Examples & Samples

Build advanced automated test suites
Work with the development and test engineering teams to automate testing
Conduct research on emerging technologies
Analyze and decompose a complicated software system and design a strategy to test this system
Train and mentor other team members

Applink Validation Engineer Resume Examples & Samples

Work with the latest technologies, smart phones, and web services
Test and deploy mobile applications in-vehicle
Develop new methodologies to validate the Applink SDK. Visit www.developer.ford.com for more info
Primary responsibility of the AppLink Validation Lead Engineer will be to perform the project based testing activities, the development of the design validation plan including coordination of test activities, adhering to approved testing methodologies to ensure a high level of excellence execution and quality is reached prior to implementation
Ensure that unit and integration tests developed internally to each product and across multiple cross-functional teams all roll-up to provide full system and interface testing coverage prior to system delivery and implementation to clients
Participate in design reviews for new features, product enhancements and other new designs with Product managers and Developers
Specifying customer-driven product requirements and User Acceptance Testing
Assess testing requirements and provide estimates of testing effort and resources
Develop new methods and strategies to test the AppLink SDK on various platforms, (Android, IPhone etc.)
Design & Create a suite of automation tools and utilities to test the integration between Mobile Apps and the Sync Infotainment system
3 years plus experience in work, intern, or academic research related to Software Engineering or as a Validation Engineer
Experience with programming / development tools and SDK’s from Apple, Android

Embedded Modem Validation Engineer Resume Examples & Samples

BS or Higher in Electrical Engineering or Computer Science
3 year experience in automotive systems engineering that includes Telematics
Automotive/Telematics/Wireless component /system design, development, testing experience
Thorough understanding of Vehicle CAN/LIN communication buses and Vehicle Diagnostics
Thorough understanding of embedded module architecture: Microcontrollers, SoC, Flash, RAM, device drivers etc
Thorough understanding of vehicle to cloud connectivity: APN, VPN, TCP/IP stack etc
Understanding of cellular networks (BSC, MSC, VLR, HLR, PSTN, ISDN, AuC, GMSC etc) Base Station message traffic debugging

Senior Validation Engineer Resume Examples & Samples

Develop strategy for, Schedule, plan, author, and execute as needed verification and validation test protocols and reports to support product commercialization and manufacturing of an automated genetic analyzer for In Vitro Diagnostic (IVD) use (hardware, software, assay chemistry) according to schedule
Review and approve validation project documentation
Coordinate and interface with R&D (Assay and Instrument), Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to assure successful project execution
Provide Quality leadership oversight for validation deviation investigations to resolve execution or result discrepancies and participate in the resolution of deviations and corrective/preventive actions
Analyze and report trends in manufacturing and quality
Support development of best demonstrated validation practices in the validation department, based on current industry practices and guidelines and in accordance with appropriate regulatory agency validation requirements (GAMP, FDA, GHTF, ISO, IEC, EU, Health Canada)
Use statistical techniques, sampling plans, DOE, Gage R&R and other quality engineering tools as needed in performing job duties
Author assigned Standard Operating Procedures (SOPs) to ensure compliance with Company policies and federal regulations
Evaluate software and computer systems vendors for Part 11 compliance, audits existing systems, and addresses validation gaps and needs
Provide computer systems validation support for electronic quality management systems, spreadsheets, databases and other systems subject to 21CFR Part 11 requirements
Manage company-wide equipment calibration program to include oversight of outsourced calibration activities, scheduling, and validation of equipment and systems where applicable
Perform other duties as assigned by the Sr. Manager, Quality Systems
Minimum of a Bachelor's degree (or equivalent) and 5 years of experience in the medical device industry
Minimum of 5 years of experience in a medical device (IVD preferred) environment acting in a validation leadership role responsible for the leadership and execution of validation and qualification of manufacturing and QC laboratory equipment, process validation, software validation, computer systems validation, and utility systems qualification
Experience working in a start-up environment and providing influence and leadership to new product development teams and technical associates required
Knowledge of molecular diagnostics desired
A combination of experience and/or education will be taken into consideration
Experience leading validation projects including working with and influencing management and cross-functional teams required
Understanding of regulatory requirements and standards including 21CFR Parts 11 and 820, ISO 13485 and 14971 and process improvements related to product realization
Project Management experience and Lean Manufacturing or Six Sigma certification preferred
Personal computer operations and Microsoft Applications (Word, Excel, Power Point, Project, Visio)
Strong customer-service orientation with a focus on delivering quality results
Ability to organize and prioritize, flexible with the ability to manage multiple duties and tasks
Motivation and skills to work in a team-oriented environment and a desire to work in a company that places a high value on cooperation and group achievement

Senior Conformance Test & Validation Engineer Resume Examples & Samples

Preparing and delivering conformance test reports and status overviews
Generating bug reports of RF and RRM issues
Working with test management and automation processes and systems
Support the preparation of conformance test campaigns on R&S and Anritsu test systems
Drive the test coverage for RF/RRM on or development UE platforms
Managing hardware and software configurations and updates to test systems

System Validation Engineer Resume Examples & Samples

Developing system level test plans
Developing validation methodologies and environments
Defining and creating test cases and test scripts
Performing manual and automated testing
Analyzing test results and helping with issue investigation and characterization
IP Networking, including experience with Layer 2 (VLAN, LACP, LLDP, ACL, QoS, Spanning Tree), Layer 3 switching/routing, along with sound knowledge of routing protocols such as OSPF, RIP, and BGP, and configuring DHCP, DNS, NTP, TCP/IP, FTP, SCP, and SSH
SDN
Programming experience in Perl, Python, and C languages
Test Plan, Test Case, and Test Script Development
Experience using Linux and Ixia/Spirent test equipment
Hands-on experience with network switches and routers

System Validation Engineer Resume Examples & Samples

Must have a BS or MS in Electrical Engineering, Computer Engineering or Computer Science
Minimum 3 months experience of Strong knowledge in Computer Architecture
Minimum 3 months experience with Programming Languages (C/C++/Java/Python)
Minimum 3 months experience with Logic Design & Validation
Experience with Windows/Linux Kernel & device driver
Experience with Verilog/VHDL

System Validation Engineer Resume Examples & Samples

Must have PhD in Electrical Engineering, Computer Engineering, or other science/engineering related field
Minimum of 3 months experience with malware analysis
Minimum of 3 months experience with software security
Minimum of 6 months experience with security methodologies and/or security framework
Minimum of 6 months experience with security technologies (for example, authentication, cryptography, secure protocols), security vulnerabilities and attack profiles
Minimum of 6 months experience with x86 and C development skills
Minimum of 6 months experience with software and/or hardware testing and tools, low level debug

System Validation Engineer Resume Examples & Samples

Bachelors or Master's degree in Electrical Engineering, Computer Engineering or Computer Science
Minimum 3 month experience C/C++ or scripting languages (Perl, Python)
Minimum 3 month experience in validation and/or debugging
Knowledge of PC architecture and Intel chipset, Parallel computers, HPC architecture
Excellent hardware and/or software interfacing skills
Knowledge of Linux development

Senior Validation Engineer Resume Examples & Samples

A passion and demonstrated success delivering products to real customers (OEMs and ISVs)
Experience in software testing, quality assurance and systems validation is required
Experience in developing automated test tools and infrastructure
Experience in scripting with tools such as JUnit, Perl, Python or Linux and Windows shell scripting
Experience working with Linux, and/or Android development environment is a plus
Familiarity with Android SDK and adb tool is a plus
Familiarity with C# and Java is a plus
Work closely in an agile team to deliver exciting new capabilities as part of the Intel RealSense SDK. Coordinate closely with other teams in Russia and Israel as needed to assure smooth delivery of the RealSense SDK products
Create automated tests for components to enable agile development and high quality, and perform some manual audio and visual testing
Create and perform white box testing such as code coverage, and black-box testing such as functional testing
Building, troubleshooting and stabilizing early Alpha, Beta, and Gold systems running on Windows
Setup and configuration of non-production systems such as laptop Haswell and beyond, along with Atom based tablets/netbooks
Work on build systems, installers, scripting, unit test systems such as NUnit, JUnit, etc

Analog Validation Engineer Resume Examples & Samples

Must have BS or MS in Electrical Engineering or Computer Engineering
Minimum 3 months experience working in a hardware lab with test equipment, computer systems, and/or test stations
Minimum 3 months experience with mathematical and/or statistical analysis, including knowledge of JMP and/or Matlab
Minimum 3 months experience working in a hardware lab with test equipment, computer systems, and test stations
Minimum 3 months experience with signal waveform transmission effects

System Validation Engineer Resume Examples & Samples

BS in Computer Science, Electrical Engineering or Computer Engineering
Minimum 3 month experience with software/programming languages (C, C++,Perl, Python, etc.)
Minimum 3 month experience in writing & debugging code, working in a lab with test equipment, computer systems, and/or test stations

Senior Validation Engineer Resume Examples & Samples

Working closely with design engineers, micro-architects, other team members to ensure high quality of testplans, functional coverage, and tests
Strong discipline and attention to detail in ensuring effective high quality validation that minimizes bug escapes to higher levels of validation
Coordinate validation activities within the cluster to ensure validation goals are met during each milestone of the project
Development of testplans, testbench, BFMs (bus functional models), checkers, trackers for assigned areas of the chip
Testplan execution involving test writing/debugging and driving bug closure
Development of functional coverage groups/points and achieving coverage goals
Contributing to process improvements where applicable, and gaining domain expertise to be able to independently validate effectively
Ability to deliver high-quality output against deadlines and able to work effectively in a cross-site team environment
Very strong background in logic verification with a good understanding of logic design concepts
Strong experience with testplan/testbench/bus-functional-models/checkers/trackers development, and test writing/debug
Familiarity with the ASIC design flow and working knowledge of 3D Graphics

System Validation Engineer Resume Examples & Samples

Master of Science degree or a Bachelor of Science degree in Computer Science, or Computer Engineering or Electronic Engineering
Strong software background, including experience with Linux* drivers and/or kernel; Solid experiences in embedded software validating
Excellent Linux* software development, testing and debugging skills in C and/or C++
Experience in Python scripting development under Eclipse platform; Experience in Linux* scripting language like shell script, Perl etc
Familiarity with Linux* development environment and a proven track record in software product development through a full life cycle
Technical and problem solving skills to define and execute tasks independently and strong written and verbal communications in both English and Mandarin

System Validation Engineer Resume Examples & Samples

At the Masters level, a minimum of 3 years experience with design and/or validation experience
At the Bachelors level, a minimum of 4 years experience with design and/or validation experience
For either degree
Minimum 2 years of Post-Si Validation
Minimum 2 years experience with Intel ITP knowledge, TAP and debug hooks
Minimum 3 years experience in silicon debug
Minimum 3 years experience in the following skills
Perl/Python scripting knowledge
CPU architecture
C/C++ Software programming
Board and system operation, validation and/or development
1+ year of low power measurement and debug
1+ year experience in at least one of the following
Low Power Design or Testing
CPU Core Validation
Design for Debug Validation
2+ years experience in embedded software debug
2+ years experience in software debug tools (logic analyzers, high-speed scopes, micro and/or pico probing)

System Validation Engineer Resume Examples & Samples

Developing a verification testing process that validates the testing at all levels of the organization
Analyzes & understands the validation & debug processes, drives new/better/best methods, improves our capabilities and efficiency
Interface with systems engineering, and development teams
Interface with management to provide regular reports
Propose, implement improvements and keep up with new technologies and requirements
Convince management of new ideas, concepts and solutions
Drive the solutions to successful conclusions
Breadth of wireless expertise with an ability to dive into details when required
Interact with marketing, concept, systems and development teams to understand the issues and in driving solutions
Increases knowledge of customers, how they use our products, and how to apply this knowledge to our validation
Positioning standard bodies, operators, network equipment vendors, equipment manufacturers towards Intel solutions (example drive test strategy and test needs of new technologies)
BS or MS in CS plus 6 years of applicable experience
6+ years of experience working in Windows
2+ years of experience Android environment
6+ years of experience in working with Wireless Technologies
6+ years of Software Development Skill in C, C++, and/or Java
6+ years of In depth technical expertise of the Validation Functional Domain
6+ years of working knowledge of SW Validation Tools and Processes
3+ years experience testing of Wireless Solutions
Proven and strong analytical and problem solving skills
Proven ability to mentor and coach teams
Team player, independent, self-starter
Energetic w/ability to adapt to changes in fast-paced environment
Ability to understand, identify efficient and effective tracing/debugging tools required for new modem platforms
Ability to anticipate new problems based on roadmap and market needs ahead of time
Ability to take a new problem, understand technical issues, boundary conditions and logically arrive at an efficient/competitive solution

Validation Engineer Resume Examples & Samples

Knowledge of USB Specification
Knowledge of mobile storage (eMMC/ SD Card/ UFS)
Thorough knowledge of Windows/Android internals
Development in a Linux environment (kernel modules development would be an advantage)
Good knowledge of hardware programming aspects

Validation Engineer Resume Examples & Samples

Working with the in house product teams develop and document the SOW (i.e. Requirements HW and SW), HLD (High Level Design), LLD (Low Level Design), Test System Commissioning procedure, Test System User Manual
Work in partnership with outside suppliers to develop the test systems as required
Conduct peer reviews and hands on onsite/offsite debugging/commissioning of test system HW and SW with supplier on their test system deliverables prior to release
Develop and diligently execute a systematic release process with the test system supplier for their expected deliverables on the test system. (e.g. HLD (High Level Design), LLD (Low Level Design), Test System Commissioning procedure, Test System User Manual etc.)
Support the selection and design of new equipment and custom Test Systems
Lead and Conduct peer reviews within the V&V team on all test systems deliverables developed in-house /suppliers
Act as a lead liaison between the Validation Test Engineers and the Supplier in understanding and defining the needs for test system hardware and software
Work onsite/offsite at Validation Test Execution facilities with Validation Engineers/Technicians to develop/debug test stand infrastructure
Function as a TEAM PLAYER within the V&V and the Magna Electronics Product Development Team sharing all information with team and coaching/training/helping team members as required
Design, Develop and Execute Validation Testing as required on projects including deliverables such as but not limited to Test Plans, Test Results, and Test Reports etc
Develop Project Test Schedule Timelines/Deliverables, for various projects and Test Systems
Support the project team in root cause analysis on Validation Test Issues (e.g. 8Ds)
BSEE required, MSEE desired
Experience with National Instruments HW, Labview required
Experience with one or more of C, C#, Matlab/Simulink, Electrical Circuit Design aspects desired
Experience with CAN, LIN and other automotive networks and related tools required
Excellent team player who is always willing to document and share knowledge and information with all team members as required
Experience with ADAS products development/testing experience desired
Excellent communication, interpersonal, and technical skills

Senior Validation Engineer Resume Examples & Samples

30%-80%
Write, execute, summarize, review, approve and lead validation activities in the following areas
Equipment
Steaming (SIP)/ Autoclave
Validation Maintenance
Validation document control and archival program
Bachelor's degree in a technical discipline, preferably engineering or biological sciences
Minimum of 8 years pharmaceutical and/or biopharmaceutical industry experience
An advanced degree or additional industry certification is a plus

Senior Validation Engineer Resume Examples & Samples

Detailed list of main areas of responsibility
Commissioning and Qualification of critical utilities including but not limited to
Commissioning and Qualification of equipment and qualification of laboratory equipment
Commissioning and Qualification documentation generation, review and approval, where appropriate
Review of computer system validation documentation for upgrade to laboratory equipment software and utility PLCs

Validation Engineer Resume Examples & Samples

Interface with R&D (Assay and Instrument), Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to support the validation activities that will assure successful project execution
Provide Quality input for validation deviation investigations to resolve execution or result discrepancies and participate in the resolution of deviations and corrective/preventive actions
Provide Quality review and assessment of associated change requests related to processes, equipment, material, facilities, software, and computer systems
Author assigned Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidances to ensure compliance with Company policies and federal regulations
May help oversee software development life cycle (SDLC) for medical device software to ensure compliance with IEC62304
Contribute to the evaluation of software and computer systems vendors for Part 11 compliance, audits existing systems, and addresses validation gaps and needs
Support the management of equipment calibration program to include oversight of outsourced calibration activities, scheduling, and validation of equipment and systems where applicable
Participate in risk analysis activities including using risk based approach in design of validation protocols
Provide training and guidance to other departments concerning validation requirements and protocol execution
Perform other duties as assigned by the Sr. Specialist, Quality Engineering
Minimum of a Bachelor's degree (or equivalent)
Minimum of 5 years of experience in a medical device (IVD preferred) environment acting in a validation engineer, associate or specialist level role responsible for the development and/or execution of validation and qualification of manufacturing and QC laboratory equipment, process validation, software validation, computer systems validation, and utility systems qualification
Knowledge of molecular diagnostics is desired
Must possess in-depth knowledge of medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems
Experience with quality engineering tools and techniques including: statistical analysis, sampling plans, DOE, Gage R&R, CpK, and AQL

Validation Engineer Resume Examples & Samples

The person in this role will be instrumental in working with other members of the Quality, Manufacturing and Engineering organizations to develop and execute the validation studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals
The person in this role must have the ability to analyze data, quantify risks, and identify gaps independently
Must have the ability to propose solutions to problems and escalate issues with proposed solutions to management as necessary
The person in this role must be able to make decisions on his/her own as it pertains to individual projects, managing priorities, and timelines
Consult with supervisor, subject matter experts, and senior engineers as appropriate

Quality Validation Engineer Resume Examples & Samples

S/he will be required to complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with quality system and the requirements
S/he will be required to create and effectively execute validation plans and achieve key project deliverables on time and within budget times to meet customer requirements
S/he will be required to project manage and lead cross functional teams to introduce and validate new processes/ new technology. Provide training and guidance to others on validations as required
As required s/he will lead and or participate in CAPA and other cross functional improvement teams
Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practice. Assess customer's validation needs and propose innovative solutions
Maintain validation and other records in accordance with the quality system requirements, which show that products manufactured meet the requirements of end users, customers, regulatory authorities and the company
Investigate, trouble shoot, disposition and report on validation failures: system failures, non conforming products and other product defects
The successful candidate should have primary degree in Quality Management, Engineering, or Science, with a minimum of 3 years validation experience

Validation Engineer Resume Examples & Samples

Manage Validation of automotive components for multiple programs
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
Create test setups and fixtures to properly operate, monitor, and orient the product while under test
Create cost and timing plans for all quoting activities
Create and manage Validation Test Plans including Analysis/Development/Validation Plan and Report Form (ADVP&R)
Coordinate and track validation testing activities
Interact with external test facilities for the execution of validation testing
Bachelor’s Degree in Engineering or Technology; or Associates Degree in Engineering or Technology with engineering experience in an automotive environment
Technical Understanding of environmental level testing, temperature, vibration, humidity, enclosure, and associated electrical type tests
Computer proficiency (i.e. word processing, spreadsheets, presentations, databases, etc)
Demonstrated ability in the creation of Validation Test Plans and coordinating and tracking validation testing activities
Demonstrated ability to conceptualize, coordinate, integrate internal data and clearly articulate concepts, ideas, and other issues relating to test, hardware, and software. Must be able to operate standard and specialized equipment related to the job. Ability to calculate and analyze data, generate reports, present information, etc
Strong organizational, project management, and leadership skills to prioritize, coordinate projects, manage conflicting needs, and deal with many issues at one time. Must be able to work independently
Demonstrated strong written and verbal communication skills in order to effectively communicate with internal and external contacts and represent the organization in a professional manner when performing job duties. Must have excellent interpersonal skills to exercise influence at various levels and functions
Demonstrated ability to thoroughly research, recommend, present information and oversee implementation of new products, materials, and processes
Excellent communication/negotiation skills. Communicates and works with peers in a positive, cooperative way, maintain productive relationships with key functional areas
Strong leadership skills. Must be able to work independently with considerable latitude for independent action or decision
Demonstrated troubleshooting skills where problems are often difficult and complex

Validation Engineer Resume Examples & Samples

Assist GMP site director in developing and implementing validation processes across the full scope of manufacturing operations and building systems. 60%
Provide oversight to site functional teams to ensure they maintain compliance with all documented validation policies and procedures within the plant. Specifically but not limited to: IQ, OQ, PQ, and PPQ validation, change control, and open deviations. Ensure that site training program drives compliance to the latest validation and cGMP requirements. – 20%
Maintain a thorough knowledge and understanding of applicable Validation and cGMP Regulations, Regulatory Agency Guidelines, Industry Association Guidelines, and Good Practices. Support leading the practical interpretation and implementation of Regulations, Guidelines and Good Practices, to ensure that all site activities are compliant. Ensure that documentation and records are compliant. – 10%
Support site lead in any visit, audit or contact with Regulatory Agencies. – 5%
Work with other sites to ensure that good practices are shared and reapplied, consult with other QA organizations to share and reapply good practices. - 5%
Experience with FDA regulated industries (Medical Devices or Pharmaceutical)
Strong oral and written communication and presentation skills
Experience in writing and executing protocols including complex systems such as Process Validation, cleaning validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems
Ability to manage complex projects and timelines in a matrix team environment. Strong project management and organizational skills
Demonstrated interpersonal skills including strong negotiation and facilitation skills
Demonstrate a clear understanding of cGMP

Validation Engineer Resume Examples & Samples

Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems
Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team
Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained
Ensure validation documents are up-to-date (primarily project MVPs and key inputs)
Manage the execution of the product/process validation as per the MVP and project plan
Work directly with customer validation representatives to define inputs and requirements to the MVP
Ensure all results and data are correct and follow-up on any gaps or discrepancies
Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment
Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions
Maintain validation procedures and templates up to date, focusing on continuous improvement

Senior Validation Engineer Resume Examples & Samples

Experience in executing validation studies and strong manufacturing floor experience as it pertains to validation execution
Formal leadership experience with demonstrated effectiveness in developing validation strategy, leading complex validation projects and motivating and developing personnel
The successful leader exemplifies trust and openness and a willingness to partner with others
Comprehensive knowledge of global cGMP requirements and expectations (US, EU, Japan, ICH, PIC/S, WHO) as they pertain to validation
Ability to lead cross-functional projects individually and with dedicated staff members
A desire and skill to work as a team member and to influence, and work through others to ensure coordinated goals are achieved
Willingness to receive and listen to feedback as well as provide constructive feedback to peers / management
Ability to work in a fast paced environment and ability to manage multiple projects and priorities

Validation Engineer Resume Examples & Samples

Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs), Process Qualifications (PQs), and System Summaries
Provide technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment
Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards
Assure that all validation test procedures are in line with current technology, corporate and governmental regulations
Review and Approve validation protocols and assessments from a quality system documentation perspective
Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS's), Factory Acceptance Tests (Fat's) and any other associated validation issues
Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant
Implement improvements to computer systems lifecycle in alignment with site and corporate requirements
Provide support for all process and utility control systems
Perform required maintenance tasks on computerized systems including periodic reviews
Develop procedures to manage computerized systems where required
Coach operations team in the efficient use of process and utility control systems
Develop and present project plans to project management senior staff

Validation Engineer Resume Examples & Samples

Engages and Assists product engineering in generating ADV and DVP&R plans
Test planning and test management
Lead electrical pump test systems
Analyzes Customer SORs, RFQ, Specifications, etc
Derives Internal Test Plans, Equipment Utilization forecasts, sample sizes, Test Instructions, Test requests, Tear Down reports, Test reports etc
Coordinate the development and purchasing of test equipment for the projects assigned to
Design and purchase test fixtures
Define, create, develop and verify systems test fixtures
Support product development and manufacturing team in development
Supply customers with technical expertise in the areas of product testing and validation of engine components
Ensures that by applying reliability engineering principles and methods, potential reliability problems are detected at the early stage of the product development cycle and that the level of risk in the product is determined
Ensures the lesson learned during testing must be communicated to product engineering team
Participate and support APQP activities as an active core team member
Continuous improvement of the verification methods
Maintenance and enhancement of test environment
Participate in all TS16949 and ISO14001 activities
Ensures that safe working procedures and good housekeeping practices are adhered to at all time, and enforce guidelines/rules outlined in the Employee Handbook and Company policies
Occasional travel is to be expected, both domestic and international. May be required to work “on-site” at customer locations, or similar, for different periods of time
Initiate plans and ideas for cost reduction and/or quality improvement measures
Undertake any other reasonable assignments or duties assigned by manager
College Diploma or University Degree in Electrical Engineering or Mechatronics
Three to Five years minimum experience with electronic control systems and electromechanical system design and development. As well, experience in electrical, control system design and testing system design
Possession or eligibility Professional Engineering Ontario license would be an asset
Knowledge of ASME, SAE, ISO9001/QS – 9000/TS16949 and other industry/customer related standards
Knowledge of GD & T
Knowledge of techniques and processes used to produce prototype components
Experience in a design and development manufacturing environment preferable in engine and/or transmission pumps or other related experience. Ex. oil pump, water pumps, and vacuum pumps
Blueprint reading, advanced measuring techniques, computer literate
Must have experience with equipment selection, choice of technology and economic appraisals
Must be able to communicate fluently in both written and spoken English
Ability to discuss and direct technical discussion
Ability to prepare and conduct customer presentations on PowerPoint
Must be willing to complete projects based on constrained timelines and work overtime if necessary
Must have demonstrated good working performance
Must be a self – starter and be willing to travel to customer locations
Work in compliance with the provisions of the Act and the regulations
Use or wear the equipment, protective devices or clothing that his employer requires to be used or worn
Report to his or her employer or supervisor the absence of or defect in any equipment or protective device of which the worker is aware and which may endanger himself, herself or another worker
Report to his or her employer or supervisor any contravention of the Act or the regulations or the existence of any hazard of which he or she knows; and
Shall not remove or make ineffective any protective device

Validation Engineer Resume Examples & Samples

Ability to work as part of a multi-disciplined team to convert existing equipment or install new equipment for high volume medical device manufacturing for current and for new products as they are introduced
Demonstrate equipment capability before validation activities commence
Responsible for developing, reviewing and executing validation protocols & reports
Align with all stakeholders on identification of acceptance criteria as early as possible in the process
Providing engineering support to manufacturing operations and participation in a team involving engineers and technicians to help the group achieve its objectives
Data collection, data interpretation and analysis, root cause analysis and report writing
Quality and risk management
Initiate and implement change control activities in accordance with site procedures
4/5+ years of experience in the medical device and/ or pharmaceutical industry. Specifically experience in Quality, Process Development, Equipment or Process Validation
Experience of commissioning and qualification of complex and bespoke manufacturing technology
Strong problem-solving and critical thinking skills
Providing engineering support to manufacturing operations
Excellent organizational skills with ability to prioritize and work effectively on multiple tasks

Validation Engineer Resume Examples & Samples

To lead CQV efforts with new equipment and processes from initial specification through to handover for PQ
Write, review and update the Master Validation Plan and area specific Validation plans
Perform IQ, OQ, PQ qualification/validation on processes, equipment and systems in conjunction with suppliers as appropriate
Monitor trial, engineering and validation batches to ensure appropriate conditions are met and required samples are taken
Co-ordinate delivery of samples to the laboratories and co-ordinate testing of same
Co-ordinate shipment of samples, if required
Co-ordinate the individual tasks required to validate processes equipment etc
Carry out Periodic Reviews of Validated Systems
Participate, when required, as a member of multidisciplinary site teams, e.g. Cross Functional Investigation Team
Write, review and update Standard Operating Procedures (SOP's) in accordance with site and corporate requirements
Compile and maintain all relevant documentation for submission to management (protocols and reports)
Bachelor of Science/Engineering degree or equivalent
Knowledge of cGMP's and other worldwide regulatory requirements
Excellent problem solving ability, computer knowledge and oral and written communications skills

Validation Engineer Resume Examples & Samples

Responsible for understanding equipment operation
Responsible for developing, reviewing and executing validation protocols & reports. (IQ, OQ and PQ)
Align with all stakeholders on identification of acceptance criteria
Providing engineering support to manufacturing operations and forming part of a team involving engineers and technicians to help the group achieve objectives
2 + years of Quality, Process Development, Equipment or Process Validation experience in the medical device and/or pharmaceutical industry
Excellent report writing ability

Validation Engineer Resume Examples & Samples

Risk Assessment, IQ, OQ, PQ, PV, CPV Validation
Validation of process equipment (manufacturing, filling and packaging) and utilities, and facility qualifications
Re-Validation of existing manufacturing and cleaning processes, equipment, utilities and facilities
Writing and reviewing of protocols, reports, assessments and SOP's required for the above
Scheduling and execution of validation studies, in co-operation with external vendors/ consultants where required
Giving input into planning materials, human resources, and time frames for Validation studies
Ensuring that the personnel involved in the validation studies have relevant training
Evaluating deviations and change controls relevant to the validation study
Minimum 4 years' experience as a Validation Engineer within the pharmaceutical industry or similarly regulated industry
Experience in aspects of Engineering, QA, validation and GMP

Validation Engineer Resume Examples & Samples

Lead SW validation testing, analysis, and reporting for production and experimental software
Develop comprehensive and robust verification methods (DVMs) supporting both software integration testing and requirement validation
Implement DVMs in an automated HIL environment using Python-based test scripts
Develop automated analysis and reporting methods using Python and Matlab
Maintain feature-specific requirements traceability matrix
Maintain test scripts in version control system
Troubleshoot embedded system faults, including hardware, software, and test bench related functionality
B.S. in Electrical Engineering ,Controls Engineering or Computer Science Engineering with a 3.0 or higher GPA
1 + years experience with SW integration testing and validation strategies, including black-box and white-box approaches
Coursework or projects with embedded control system development and validation, preferably in automotive (CAN/LIN) domain, highly desirable
Knowledge or interest in advanced testing methods (formal methods, for example) desirable
Technical writing and data presentation skills strongly desired
Excellent written/reading and verbal/listening communication skills required to work well with a globally diverse team

Validation Engineer Resume Examples & Samples

Conduct field cleaning validation testing including performance of visual inspection, and the collection of rinse water samples, swab samples, and/or extraction samples. Equipment will include: bioreactors, fixed tanks, transfer lines, chromatography skids, filtration skids, portable vessels, centrifuges, homogenizers, ultrasonic washers, glasswashers, lyophilizers, vial washers, chromatography columns, filter carts, and filter housings
Practice highest regard for Safety: Work with potentially dangerous systems, some which utilize high pressures and temperatures
Act as Subject Matter Expert (SME) on periodic re-validation of commercial product equipment and manufacturing. Possess ability to answer validation questions and interact with various regulatory agencies
Act as validation reviewer for operation's SOP's with validation cycle parameters and possess ability to quickly address operations’ issues with equipment validated cycles

Senior Validation Engineer Resume Examples & Samples

Responsible for periodic revalidation of major process equipment in Clinical Pilot Plants and in Commercial Facilities
Conduct thermal validation testing using thermocouple sensors and data collection instruments on equipment including GMP autoclaves, decon autoclaves, waste inactivation systems, dry heat ovens, lyo cabinets, bioreactors, holding tanks, portable tanks, transfer lines, and controlled temperature units (CTUs)
All work includes protocol write-up, sampling plan generation, scheduling, Lock Out/ Tag Out, testing, report write-up, review, approval, and closeout. Lock Out/ Tag Out participation is to ensure zero energy of equipment and permit safely breaking into lines for testing
Perform validation review and support for pilot plant campaign and master cell bank readiness plans
Conduct out-of-specification (OOS) investigations and author OOS reports
Update and maintain validation SOP’s for conducting all validation work to include: sample preparation, sample collection, sensor calibration, and final report documentation packages
Proven record of providing excellent internal and external customer service

Validation Engineer Resume Examples & Samples

Generate validation documentation (URS, IQ, OQ, PQ & validation reports) and oversee the execution of protocols for equipment and processes
Develop smart, cost effective validation strategies which deliver robust processes whilst maintaining compliance to relevant regulations
Ensure consistency on validation/qualification approach across systems and projects
Work directly with validation representatives from the wider organization to define inputs and requirements to the MVP

Validation Engineer Resume Examples & Samples

Responsible for performing validation of equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements
Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages
Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements
May also investigate and trouble-shoot problems which occur, and determine solutions
Coordinates and executes validation change control and preparation of draft protocols, reports and data tables
Maintains all documentation pertaining to validation
Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups
Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel
As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies
Independently applies validation principles to work assignments, reviews and approves documents and resolves problems
Coordinates assigned projects and represents department on project teams
May provide day-to-day guidance and training to validation technicians
Serves as an information resource to validation technicians, contractors and vendors
Resolves validation issues of moderate scope with limited direct supervision

Validation Engineer Resume Examples & Samples

30-80%: Write, execute, summarize validation activities in the following areas
Cleaning
Steaming / Autoclave
Computer Systems
Plant Automation
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

Validation Engineer Resume Examples & Samples

Perform data analysis on test results and present to the development teams / customer
Develop project test schedule, and timing plans and use to track all testing deliverables
Develop and release all relevant validation engineering deliverables in compliance with
Design, develop, and deploy validation testers, load boxes etc. to perform
Perform work assignments as a highly competent engineer, requiring independent
Comprehensive knowledge of customer environmental requirements
Working knowledge of ISO/IEC standards
Working knowledge of HIL procedures and Equipment
Matlab/Simulink, Labview
CAN, LIN and other automotive networks and related tools
Advanced knowledge of MS Office package
Working knowledge of problem solving techniques

Senior Validation Engineer Resume Examples & Samples

Develop strategies for, Schedule, plan, author, and execute as needed verification and validation test protocols and reports to support product commercialization and manufacturing of an automated genetic analyzer for In Vitro Diagnostic (IVD) use (hardware, software, assay chemistry) according to schedule
Review and prepare for approval, validation project documentation
Author assigned Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidance to ensure compliance with Company policies and federal regulations
Provide computer systems validation support and guidance for electronic quality management systems, spreadsheets, databases and other systems subject to 21CFR Part 11 requirements
Perform other duties as assigned by the Manager, Quality Engineering & Validation
Leads efforts to establish processes and procedures for a quality control laboratory that meet internal standards and external regulatory requirements. Evaluates processes and documentation for compliance with quality standards and cGMP, ISO 13485 and FDA regulations
Minimum of Bachelor's degree in Engineering discipline
Minimum of five (5) years of experience in a medical device (IVD preferred) environment acting in a validation engineer, associate or specialist level role responsible for the development and/or execution of validation and qualification of manufacturing and QC laboratory equipment, process validation, software validation, computer systems validation, and utility systems qualification
Experience in participating in validation projects including working with and influencing management and cross-functional teams required

Validation Engineer Resume Examples & Samples

Opstellen, beoordelen en rapporteren van initiële en periodieke validaties
Begeleiden en uitvoeren van validaties
Opstellen van Validatie Master Plannen voor projecten
Bijdrage leveren aan de continuïteit van de validatie / kwalificatie van productieprocessen en systemen
Zelfstandig en concreet communiceren met productieafdelingen en interne en externe uitvoerders van validaties / kwalificaties
Het in samenwerking met de productie afdelingen implementeren van product- of procesverbeteringen en deze begeleiden op het gebied van validatie
Beleid mbt validatie toelichten bij interne, externe en corporate audits
Kennis van farmaceutische productie processen en regelgeving
Ervaring met validatie en CSV
Goede beheersing van Nederlandse en Engelse taal
Zelfstandig
Communicatief

Validation Engineer Resume Examples & Samples

Initiative, tolerance of ambiguity, and drive clarity in key focus areas
Demonstrated ability to collaborate with stakeholders outside of core group
Trustworthiness through influence and effective conflict resolution
Expert in facilitating problem solving and driving consensus
Proficient in oral and verbal communication
Technical Capacity

System Validation Engineer Resume Examples & Samples

Familiarity with Very Large Scale Integration (VLSI) Complementary Metal-Oxide Semiconductor (CMOS) logic circuit design
Good understanding of semiconductor physics and basic PC computer architecture
Creativity in problem solving and logic thinking
Strong programming skills in C, C++, Python, Perl, Java and etc
Good understanding about Operating Systems and Device Drivers would be a plus

Validation Engineer Resume Examples & Samples

Accountability for your workload
Focus
Verbal communications
Validation experience
Responsible to our communities
Ready to apply our knowledge and know-how
The drivers of our own success

Validation Engineer Resume Examples & Samples

Responsibility for the validation of new equipment and products
Assist in the creation of process validation master plans and associated projects
Responsibility for the preparation, writing and execution of validation protocols
To support production and R & D operations in the identification of process validation / improvements for new product development (NPD) and capacity constraints
Coordinating with relevant departments in the execution of validation projects and ensuring full compliance with FDA, cGMP, GAMP and other appropriate internal and external regulations and standards, as required
The drafting and publishing of applicable SOPs and the preparation of final validation reports
Specialist knowledge in validation roles within a Biotech or pharmaceutical manufacturing and controlled storage environment

Validation Engineer Resume Examples & Samples

Thorough understanding of manufacturing processes and related process equipment/sterilization
Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
2 years of experience in executing process validation
Fundamental understanding of standard pharmaceutical analytical testing

Validation Engineer Resume Examples & Samples

Develop and execute facility, process and equipment validations with regulatory, corporate requirements and business requirements
Perform process improvement studies, complete process validations and Risk Management to improve quality rates and cycle times for AcrySof IOL product line
Review for compliance to Quality System requirements, project documentation including validation and software documents
Use knowledge of statistics to assist with validation developments and process improvements
Maintain/Support the Risk Management and Validation System in compliance with International requirements
Adhere to inhouse H&S and environmental requirements
Knowledge of FDA, medical device, GMP and validation requirements
Experience in equipment and process validations
Knowledge of Statistics
Skills: Project management, problem solving, statistical analysis and word processing
Report writing expertise and highly developed people skills

Senior Validation Engineer Resume Examples & Samples

Manage day-to-day operations of Validation
Development and management of SVMP, Validation Plans, strategies, SOPs/Plan/Policies for a multi-platform, multi-product, GMP medical device manufacturing facility
Provide guidance and direction on all validation activities for the site
Determine appropriate validation methodology, acceptance criteria and requirements
Liaise with system owner, quality unit and relevant departments including ccustomers to ensure scope, execution and reporting of Validation Program meets their expectations
Participate as required in regulatory inspections/internal audits and develop strategies for key validation topics
Participate in the development/execution of validation goals and performance matrices
Engineering/Science Degree or higher from recognized institution
Thorough knowledge with regulatory requirements and local Codes & Standards (eg. FDA, EMEA, GAMP, etc.)
Extensive knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
IQ, OQ, PQ, PV, Gauge R&R experience required
Effective communicator (oral and written)
Exhibit good quality decision making traits
Meticulous and Systematic and Team Player, with strong focus on safety, quality and timeline
At least 10 years of experience in Validation/Quality unit in the Medical Device/Pharmaceutical/Biotech industry
Effectively communicates both up and down the organization and maintains a customer focus
Excellent planning and prioritization skills with the ability to multi-task and adapt
Ability to identify, define and resolve problems using a structured methodology

Senior 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
Manage and 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

System Validation Engineer Resume Examples & Samples

Courses in Object Oriented Design, Operating Systems
Knowledge in C/C++
Advantage: Experience in Linux development environments
Advantage: Experience with Python

Validation Engineer Resume Examples & Samples

Providing guidance and assistance regarding documentation and requirements for test method validation, process validation, facility, utility and equipment qualification, software validation, raw material and commodity qualification
Leading & co-ordinating Site Validation projects as required
Planning and assisting in execution of validation and qualification activities
Implementation and maintenance of a validation /qualification system at AIDD Longford that meets applicable internal and external requirements
Review of validation / qualification plans, protocols, reports, amendments and other validation / qualification records
Provide site training for test method validation, process validation and facility, utility and equipment qualification
Representing respective SME area during internal and external audits /assessments
2 years of experience in regulated industry is necessary, as this will provide a good foundation for this job function
Appropriate and accurate validation/ qualification documentation
Implemented procedures and training are in compliance with internal and external requirements

Validation Engineer Resume Examples & Samples

The Validation Engineer II coordinates and performs validation projects and protocols in support of equipment, facility, utility, product, process and cleaning validation. 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%)
Collaborate with Process Development to ensure successful process development and technical transfer to Manufacturing. (10%)
Lead and provide support to manufacturing to ensure protocols are executed as intended. (10%)
Five 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 of equipment qualification (IQ/OQ/PQ), cleaning and process validation
Trained in risk assessment or risk analysis preferred

Senior Validation Engineer Resume Examples & Samples

Independently provide and/or direct the technical validation lifecycle support for Amgen Singapore Manufacturing (ASM) application and computer system environments, including manufacturing, process development, laboratory, facilities, and utilities areas
Develop and maintain validation procedures and data integrity programs that affect multiple organizations at ASM
Work with project managers to ensure appropriate development and execution of computer validation and lifecycle requirements for site projects within schedule, budget, and quality constraints
Work with system owners to ensure systems are maintained in a validated state and all periodic compliance activities are completed as required
Apply knowledge of risk based computer validation and Part 11/Annex 11 principles and practices within and outside area of expertise to a broad variety of assignments
Investigate isolated data integrity gaps and events and potentially systemic system issues together with other stakeholders; recommend improvements to address these events and issues
Keep current with Part 11, Annex 11, and computer validation trends both within Amgen and external in the pharmaceutical industry and regulatory authorities, mostly through routine participation with internal validation network interactions
6 + years experience in computer systems support, project management, system ownership, and/or computer validation, particularly in the pharmaceutical industry
In-depth knowledge of Part 11/Annex 11 computer system, data integrity and validation processes, requirements, and policies
Knowledge and experience in application of risk based approaches to computer validation
Excellent communications skills (written, spoken, and group presentation to various levels of the organization) as well as relationship skills
Ability to handle multiple projects or initiatives simultaneously
Knowledge and mastery of troubleshooting and process improvement processes,
Ability to coach and transfer knowledge and practical concepts to other groups/ indivduals for whom computer validation is not a core competnency

Validation Engineer Resume Examples & Samples

B. S. degree in a microbiology. A degree in chemistry or biochemistry or a related field is desired
A minimum of 3 to 5 years of relevant experience
Strong organizational skills, Good laboratory techniques and operation of lab equipment
Strong problem solving ability, Good oral and written communication skills in English
Strong organizational skills and computer skills

Senior Validation Engineer Resume Examples & Samples

7+ years of relevant experience and bachelor�s degree in science or related field
5+ years of relevant experience and a MS or MBA
3+ years of relevant experience and a PhD

Validation Engineer Resume Examples & Samples

Write reports summarizing results and statistics for all equipment, product, or process validation projects
Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports
Coordinate with end users and process owners to lead development of validation protocols
Learn and understand the applicable technology and engage in technical discussions
Ensure validation program meets requirements of FDA and ISO

Senior Validation Engineer Resume Examples & Samples

Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility
Contribute and help write procedures for the Calibration and Environmental Monitoring program sustaining activities
Identify areas and opportunities to improve manufacturing facilities, processes and equipment
Provide consultation to other departments performing validation activities

Validation Engineer Resume Examples & Samples

Develop and execute validation protocols for enzyme manufacturing equipment and methods used at all levels of consumable manufacturing
Perform late stage development, qualification and validation of enzyme production methods
Analyze test results, draft validation/engineering reports and make technical recommendations
Provide technical input with respect to test method validation requirements, as needed
Minimum 3 years of experience in qualification and validation or manufacturing processes and equipment
Minimum 3 years of technical writing in many of the following areas: validation protocols, validation reports, SOPs, engineering/development reports; validation master plans
Must be an effector communicator, able to effectively work in a team environment and interface well with the organization
Expert user level experience with many of following techniques: Chromatography, HPLC, LCMS, UV/fluorescence spectroscopy, biochemical (enzyme) assays
Proficient knowledge and working application of process and equipment validation principles for regulated industries including: FDA cGMP; ICH / USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis and Design Controls
Experience with statistics, Statistical Process Control and DOE techniques is desired

Validation Engineer Resume Examples & Samples

Write Validation and Equipment SOP’s, Protocols, Final Reports and Equipment/Software Change controls
Perform validation and revalidation testing including data collection and analysis
Perform sampling for QC analysis in support of cleaning and aseptic processing validations
Work with other departments to complete validation testing
Experience with writing and executing IQ’s, OQ’s, and PQ’s as well as SOP’s and change controls
Experience with validation of WFI systems, HVAC systems, SIP and CIP, heat tunnels and ovens, autoclaves, glassware washers, cleaning validation, HEPA certification, aseptic bulking and filling operation validation and other utilities and pharmaceutical equipment validation
Experience with Data Acquisition set up, programming and thermocouple calibration

Validation Engineer Resume Examples & Samples

Defining C&Q strategies through the implementation of C&Q plans for plant utilities, facilities and process equipment
Apply thorough understanding of cGXPs, relevant plans and SOPs, routine project procedures, project management, and other training as appropriate
Lead and perform variety of CQV projects/studies in areas that may include Product/Process and Equipment commissioning and qualification
Provide hands on technical support in the design, development, and the implementation of cleaning and sterilization validation
Plan and track execution of CQV activities/documentation versus project timeline. Assist in managing work of the internal and contract resources
Perform change control assessments and write/review CQV plans, study/test protocols, and summary reports. Perform execution of study/test protocols and review test results
Perform periodic review, re-qualification and lead system decommissioning
Individual must work with minimal supervision, on assignments that are moderately complex and assure compliance with Specifications and SOP's
Supporting development of best demonstrated CQV practices within the validation department, based on current industry practices and regulatory guidelines
Supporting continuous improvement across all validation activities
Minimum of 2-3 years’ relevant experience within the pharmaceutical, biotechnology or biopharmaceutical industry
Must have experience in the principles and approaches of product/equipment cleaning and sterilization validation
Must have validation experience with preference for biologics industry. Have a solid understanding of biochemical and microbiological methods supporting site product lines
Author/review related documents including CQV plans, design qualification reports, traceability matrices, commissioning and qualification protocols, and summary reports
Lead commissioning and qualification protocol execution, and manage protocol deviations investigation and corrective action activities
Participate in design reviews and product/system based risk assessments
Proficient in Microsoft Word and Excel, Project and other desktop computing software
Able to participate in multiple cross-functional teams simultaneously

Senior Validation Engineer Resume Examples & Samples

Works independently to provide day-to-day support of the Validation function encompassing automation system validation, equipment/instrument qualification, operational controls to maintain the validated state of systems, cleaning validation and regulatory compliance
Support Manufacturing equipment / system implementations as validation SME to ensure that appropriate regulations (e.g. 21 CFR Part 11 and cGMP) are addressed during validation in a phase appropriate and risk balanced manner
Provide Validation support to prepare, assist, and participate during engineering and design of automated systems, assist with specification development, and facilitate design reviews
Reviews and approves validation deliverables on system implementation or change projects
Manages multiple simultaneous validation, revalidation, and change control activities
May develop validation deliverables as needed such as qualification protocols, gap assessments, risk/impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls
Review ETOP and commissioning documents to determine leveragability for qualification activities
Evaluate changes to the validated state of manufacturing equipment / systems through change control procedures and participate in the planning and implementation of changes
Provide training to project teams and vendors on Vertex practices, regulatory requirements, and industry trends as it pertains to validation
Support and provide input into equipment / system administration and maintenance procedures to ensure adequate controls for maintaining the validated state
Interface with Quality Document Control for managing and archiving validation artifacts for manufacturing equipment / systems
Authors and/or contributes to the development and implementation of Vertex Policies, SOPs, Work Instructions, Forms, and Templates surrounding validation
Independently solve validation related problems and implements corrective actions as needed
May participate on process improvement teams to develop guidance and procedures pertaining to validation
May participate in a regulatory inspection or due diligence activities, as requested
Clearly demonstrates an extensive understanding of quality and regulatory compliance as well as the application of these concepts
Strong understanding of GAMP and other approaches to System Development Life Cycles (SDLC)
Working knowledge of current commissioning and qualification methods, including ISPE, ICH, and ASTM E2500 methodology
Thorough knowledge of and high competence in core quality systems such as change control, deviations, investigations, CAPA management and document control
Effective at influencing others on project teams regarding validation or compliance concerns
Experience in cleaning and process validation preferred
At least 5 years of direct experience writing and/or executing validation documentation required
At least 3 years of direct experience in regulated pharmaceutical environment
Must be well organized and willing to work as part of a team
Must be able to demonstrate

Validation Engineer Resume Examples & Samples

Provide ongoing coaching and support to the cross functional team members, to share their technical knowledge and promote best practices
Ensure supply of high quality product through ensuring equipment availability, maximise performance through OEE and continuous process improvement initiatives
Provide Technical stewardship, equipment resource planning and validation schedules
Ensure highest Quality & Compliance standards
Provide Technical expertise within a wide range of technical projects within the IPT/COE, such as the validation of new equipment, improvement to the filling process etc
Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc)
At least three years experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical role in a manufacturing environment
Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements
Demonstrated leadership skills with a continuous improvement focus
Project Management Experience leading projects
Degree or 3rd level qualification (Production, Mechanical, Process, Industrial, Electrical)
Desirable evidence of Continuous Professional Development
Desirable for Six Sigma Green Belt
Desirable project management qualification such as PMP etc
Process and technology background
Demonstrated ability in holding project team members responsible for results and being decisive about non-performers
Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc
Demonstrated high level of problem solving and facilitation skills
Advanced PC skills such as Excel, Word, PowerPoint

Senior Validation Engineer Resume Examples & Samples

BE (Electrical or Electronics and Communication) with 2-6 years experience in testing of electronic controls in automobile industry
Good exposure to Automotive engineering knowledge
Good knowledge about electrical & electronics components assembly in vehicle production line
Heavy vehicle driving license
Good Knowledge of Release Management
Good understanding of Automation testing domain
Exposure to ECU hardware and electrical network testing skills

Senior Validation Engineer Resume Examples & Samples

BE (Electrical or Electronics and Communication) with 4-6 years experience in testing of electronic controls in automobile industry
Good Knowledge of Release Management Software
Exposure to ECU and electrical network testing skills

Validation Engineer Resume Examples & Samples

Develop best practice methods, workplace layout and workplace organisation to gain improved value streams, process flow improvements and identify cost saving opportunities
To take part in and give guidance to cross-functional teams rolling out the Lean Operational Excellence initiative throughout the facility
Coaching employees in Lean Techniques and Principles in order to develop an organisation wide culture of change
Deliver and teach scientific problem solving training (8 steps)
Ensure continued compliance with all Regulatory Standards
Drive the site validation function in the development and provisions of documentation for the qualification (IQ/OQ/PQ/PPQ) related to agreed Plant validations
Validation documentation

Validation Engineer Resume Examples & Samples

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
Attend and contribute to staff meetings and attend appropriate training sessions, as required
Comply with the responsibilities as outlined in the Site Safety Statement
Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and the companies' requirements, policies and procedures
Champion safe working practices and safety initiatives within their functional area

Validation Engineer Resume Examples & Samples

Day-to-day validation support to manufacturing operations including conducting equipment performance qualifications (specifically cleaning and sterilization validation)
Authoring validation protocols and final reports, executing validation studies, analysis of validation data
Resolving technical issues encountered during study execution
Providing Validation support of manufacturing investigations
This individual will be required to work in a cross-functional team and independently to accomplish validation objectives
Off-shift and weekend work may be required
B.S. /M.S. degree in an engineering/scientific field
Minimum of 4-8 years post-Bachelor’s degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry
Previous experience with equipment validation, specific experience with cleaning and sterilization validation required
Proven problem solving/ troubleshooting abilities
Working knowledge of Microsoft Office products, LIMs, and Track wise
Strong technical writing and oral communication skills
Demonstrated ability to work both independently and as a part of a cross-functional team

Senior Validation Engineer Resume Examples & Samples

Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews
Coordinate and execute approved process validation, IQ, OQ and PQ protocols for a new TBU production facility, and GMP/GLP laboratories supporting large molecule testing
Ensure validation testing performed by vendors is complete and accurate, work with vendors for issue resolution and validation deviation reporting
Represent validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation)
Support the revalidation program
Upkeep of validation standard operating procedures. Authoring and revising procedures within the electronic documentation management system
Attends regular/recurring meetings to support the production facility during campaigns
BS or equivalent experience in life science or engineering; knowledge in validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines)
Minimum 8 years of Equipment and/or Process Validation experience or combination of Validation and Engineering/Commissioning experience n the pharmaceutical industry required; preferably in biopharmaceutical products
Understanding of utility systems, process instrumentation, automation systems, and analytical equipment
10 or more years of related pharmaceutical Validation and Engineering/Commissioning experience

System Validation Engineer Resume Examples & Samples

Strong knowledge of Testing concepts, techniques, tools and processes
Knowledge of System Testing, Performance Testing, Defect Management Tool etc
To identify HW/SW/tools required for test executions and setting lab environment
Innovate technical ideas
Solaris/Linux
Strong problem solving skills, communications and interpersonal skills are required
Policy and Charging concepts: LTE, 3GPP architecture
IN (Working experience on Intelligent Networks, Rating and Charging concepts)
DB experience (preferable Aerospike DB)
Diameter (base protocol, Gy, S, Ro, Gx, Gy, Rx, Sy interfaces)
Virtualization (VMware, Openstack, Cloudband)
Testing Tools: - JMETER, SOAP UI, SEAGULL, DIAM TOOL
DSC product knowledge
SurePay product knowledge
Agile (scrum) experience
Scripting (PERL, Shell)
Web Services and Technologies (HTML, JavaScript, SOAP, REST, XML)

Validation Engineer Resume Examples & Samples

Possession of a Bachelor’s degree in Computer Science, Information Systems or equivalent from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or five (5) years related experience in lieu of degree
Foreign degrees must be evaluated for U.S. equivalency
A minimum of five (5) years of experience in software quality assurance testing
Expertise in implementing quality assurance using the Agile and BDD methodologies in a Continuous Integration environment
Experience developing test plans, requirements traceability matrix and test reports
Experience developing manual test cases
Experience with automated testing, developing automated test scripts and executing and analyzing results using Selenium
Experience testing RESTful web services
Good presentation, written and communication skills
Experience in analyzing, identifying, prioritizing, and managing software defects, and effectively working with developers in fixing, verifying, validating and closing defects
Manual test case development, Selenium scripting, Cucumber, SQL, Automated Web Services testing, JAVA and/or JavaScrpt programming
Experience with the Jenkins Continuous Integration tool
Experience with HP Quality Center and LoadRunner

Validation Engineer Resume Examples & Samples

B.S. /B.A. in Engineering or Science
1 to 3 years relevant experience in pharmaceutical validation testing discipline
Demonstrated leadership and teamwork skills, excellent analytical abilities, excellent written and verbal communication skills

Validation Engineer Resume Examples & Samples

Deliver on time validation plan and documentation (especially test procedures and reports)
Train qualification delivered on time
Customer satisfaction during qualification phase on site
Implement the validation plan including sub-system and train static and dynamic tests, in close relation with the engineers of the project
Make sure that all documentation related to qualification (test procedure and reports, calculation note, …) is made, validated by the engineers, and accepted by the customer
On customer site, organize and manage all activity and resource related to train qualification, and ensure the interface with the customer. Accountable for schedule, cost and quality of the qualification tests on site
Manage train configuration on customer site during qualification phase
Any and all other responsibilities, in addition to those mentioned above, as assigned by supervisor/manager. Any interpretation/clarification with responsibilities above will be settled by the supervisor/manager. This list of responsibilities is not all inclusive and may change, be added to or deleted from any time
Minimum of an Associate’s degree in an applicable field
Minimum of 4 years of design experience
Minimum of 2 years systems engineering experience

Validation Engineer Resume Examples & Samples

Understand test requests and co-ordinate with cross functional teams to complete the measurements
Perform data analysis and ensure requirements are captured as per the specified regulations/guidelines
Perform data quality checks and identify root causes to resolve any issues
Fulfill validation requirements by gaining knowledge on power performance, loads & component design criteria
Execute on type certificate validation requirements for new turbine configurations
Perform project management functions to plan and coordinate prototype operation
Master’s or Bachelor’s degree in Mechanical, Aerospace, Civil engineering, Electrical & Electronics engineering
Strong quantitative and analytical skills for data interpretation; Creative problem solving skills
Experience in wind turbine measurements, testing & field operations
Hands-on experience with measurement data analysis tools like FAMOS etc
Experience in project management and working with third-party contractors

Validation Engineer Resume Examples & Samples

BS or MS in electrical engineering, mechanical engineering, software engineering or related field
5 - 7 years of experience in software validation
Minimum 3 years of experience in testing using HIL and test development tools such as but not limited to: Provetech TA, Control Desk, Automation Desk, Python, and Visual Basic etc
Working knowledge of HIL HW and SW test environment including Plant Models, Harnesses, Load boxes, FIUs, Controllers etc
Fundamental knowledge of Hybrid, Electric automotive architectures

Validation Engineer Resume Examples & Samples

Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with Vention quality system and the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations
Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practice
Provide training and guidance to others on validations as required
Provide support to the NPI engineers and sales to define validation plans and times to meet customer and company requirements
Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control
Provide manufacturing quality engineering support for current business to improve quality through improved manufacturing processes and process control
Effective and efficient execution of validation and other projects : Achieve key project deliverables on time and within budget
Champion structured approach to problem solving within the organisation using cross-functional teams and six - sigma methodology

Senior Validation Engineer Resume Examples & Samples

Support the day-to-day operation of approved Validation SOPs / Plan / Policies for a multi-platform, multi-product, GMP biotech contract manufacturing facility
Develop, review and approval of Validation SOPs, templates, guidelines, Validation Protocols and Reports including supporting site discrepancies and deviations investigation / closure in line with corporate policies and standards
Provide guidance and direction on all validation activities at the Singapore site
Ensure that all validation activities with respect to cleaning, sterilization, facilities and equipment stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion
Lead investigations or troubleshooting discrepancies/deviation encountered during commissioning and qualification
Generate training materials and to conduct workshops on general validation activities
Serve as a technical subject matter expert (SME) in support of department functions
Support strategic or technical planning for new product introduction project by leading commissioning activities when required
Lead the validation effort for large-scale change implementation projects
Assist Functional Head in development/ implementation of site-wide Plans/ Policies
Represent Singapore site in the Global Validation Network Team ensuring alignment with global practices
Contribute, whenever possible, to raising the site awareness on the importance of validation at Singapore site and within the industry
Any other tasks as and when assigned by Supervisor

Validation Engineer Resume Examples & Samples

Able to collaborate with both plant and corporate organizations seamlessly
Is constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity
Is able to provide the leadership necessary to maintain a high performance culture
Develop, execute, and manage the detailed project plans and timelines for the execution of PQ/CV/PV/RV activities
Plan and execute PQ/CV/PV/RV activities
Prepare validation & change control, documentation, including protocols, summary reports, etc., for validation activities
Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts
Provide input into investigations with potential validation impact
Present and provide rationale for the validation program during periodic audits and regulatory inspections
Procure and manage contractor support for outsourced validation assignments
Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol
Support the change management system for validated equipment, utilities and facilities
Prepare, review and approve relevant sections of regulatory submissions
Serve as a representative on cross-functional and multi-site teams
Lead and facilitate the development of formulation, filling, and packaging, area SOP’s and manufacturing documents as appropriate
Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements
Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production

Senior Validation Engineer Resume Examples & Samples

Reviews and continuous improvement best practices
You are a quick learner, able to continuously master and apply new technologies
You are motivated to tackle complex problems
You enjoy technical deep dives as well as hands-on broadly scoped work

Validation Engineer Resume Examples & Samples

Manager is looking for a Test Engineer with some experience in hematology and medical technology to work in the 3rd shift
Required a B.S. in a life or physical science or engineering
Read and understand customer and product requirements
Work in a team environment to author and implement V&V protocols using peer review process
Design and conduct studies to validate performance characteristics of hematology products
Review and analyze performance data and create review summary of tests
Conduct technical reviews of test data and create verification and validation summary documents
Familiarity with regulatory and ISO requirements is a plus
Med tech experience is a plus
Minimum of 2 years relevant Medical Device V&V experience in an FDA-regulated
Knowledge in biological and diagnostics systems, preferred
Excellent oral, written communication and interpersonal skills
The ability to articulate complex technical concepts and issues in a simple, easy to understand manner
Must be able to interact effectively and work well with team members under stressful conditions

Validation Engineer Resume Examples & Samples

Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with internal Policies and Procedures
Facilitate successful team behavior within Quality Systems and across functional areas. Manage relationships externally and internally
Build cross-functional and cross-departmental support, fostering overall effectiveness. Ensure compliance through assisting in audits
Ensure that all validation activities are carried out and reported in a timely manner
Review Protocols and Summary Reports and other documentation associated with validations, as appropriate for each validation exercise
Facilitate, encourage and coordinate continuous improvement with respect to validation activities
Lead and coordinate change management process in the factory and ensure the validated state of the manufacturing process and methods is maintained
Coordinate quality risk assessment approach and ensure mitigation plans are defined, followed-up and resolved by project leaders and subject matter experts
Reduced Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking cigarettes. PMI’s RRPs are in various stages of development and commercialization, and we are conducting extensive and rigorous scientific studies to determine whether we can support claims for such products of reduced exposure to harmful and potentially harmful constituents in smoke, and ultimately claims of reduced disease risk, when compared to smoking cigarettes. Before making any such claims, we will rigorously evaluate the full set of data from the relevant scientific studies to determine whether they substantiate reduced exposure or risk. Any such claims may also be subject to government review and authorization, as is the case in the USA today

Validation Engineer Resume Examples & Samples

The Validation Engineer leads 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
Leads the testing of required configuration changes to the site Process Automation System (Delta V)
Leads validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs
Assists with a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply
Ensures alignment with BMS directives and industry guidelines on validation
Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent
Chamber validation (incubators, freezers, autoclaves)
Demonstrated proficiency in project management
Experience with sterilization validation
Practical experience with large scale distributed control systems
Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent
1604165

Validation Engineer Resume Examples & Samples

Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing
Prepare reports using IQ, OQ, PQ, and Commissioning monitoring and test data
Ensure site alignment with corporate standards and cGMP guidelines
BS or equivalent combination of education and experience in life science or engineering; knowledge in validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines)
Minimum 5 years of Equipment and/or Process Validation experience or combination of Validation and Engineering/Commissioning experience n the pharmaceutical industry required; preferably in biopharmaceutical products
Experience of successful interfacing with Facilities, Quality, Operations and Information Technology groups to develop requirements, establish programs and manage day-to-day operation
Experience of establishing overarching, comprehensive and compliant life-cycle programs for validation of process equipment, automation and utilities
Able to review Algebraic, Geometric and Statistical calculations for data analysis
7 or more years of related pharmaceutical Validation and Engineering/Commissioning experience
Validation experience with production equipment, support equipment, HVAC and other utilities, analytical lab equipment, computerized systems/automation, SIP/CIP, and cleaning verification
Cooperative, independent, critical thinking, multi-tasking and detail oriented

Senior Validation Engineer Resume Examples & Samples

Understanding & analyzing Non functional requirements of the product/solution
Assists in the development of project timelines/estimates and planning for resource allocation based on project requirement
Test Strategy Preparation, Test cases development, Test execution, Benchmarking Performance, identifying bottlenecks & reporting
Technical guidance to the team, Day to day tracking of project progress and resolving impediments
Hands on experience in functional & non-functional validation including but not limited to,

Senior Validation Engineer Resume Examples & Samples

Responsible for planning validation strategy and driving the pre/post-silicon execution through PRQ
Working closely with architect/design team to review architecture change
Collaborate with business units on Validation, Quality, TTM initiatives
Be a champion for strong engineering discipline in process
Drive continuous improvement throughout the development process
Develop and strengthen technical leaders across the organization
Ensure consistency, reuse and teamwork across server teams
Strong partnerships with the external customers are expected so that the validation techniques are optimized to meet customer needs in a timely manner
BS/MS degree in Electrical Engineering, Computer Engineering or Computer Science
7+ years of experience in validation, debugging across multiple products
Prior industry experience in leading team of engineers
Knowledgeable of Server technologies and their validation methodologies
Knowledgeable of PC architecture and Intel chipset
Passion for validation and the value it brings to the company
Strong communication and influencing skills, along with ability to work with diverse communities
Strong leadership skills with commitment to team results
Good planning skills & strong ability to multi-task

Validation Engineer Resume Examples & Samples

Author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes
Generate and execute Installation, Operational and Performance qualification (IQ, OQ, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements
Coordinate and oversee validation protocol execution or validation activities with cross-functional departments
Evaluate and analyze qualification data collected during projects while verifying acceptability of the data and compliance with the approved protocol
Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed by the Validation Committee
Provide input and assist on the development of validation policies and procedures
Effectively interact and provide validation guidance to other departments
Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectation
Provide input and assist in change control and risk assessments for validated systems
Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP reflect validated conditions
Assist department manager on projects/managerial responsibilities as needed
Requires a BA/BS in Life Sciences, i.e. Biology, Microbiology, Biochemistry or Chemistry
Minimum of 5 years work experience in a biopharmaceutical/pharmaceutical manufacturing environment of which 3 years are directly involved in validations
Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environment
Additional experience may include, but not limited to: knowledge and understanding of manufacturing processes, Computerized System Validation, Software Validation and equipment/process gap analysis
Understanding of Good Automated Manufacturing Practice (GAMP), SDLC, Risk Assessment and 21 CFR Part 11 Electronic Records and Electronic Signatures
Knowledgeable with Programmable Logic Controllers (hardware and software)
Normally receives general instructions on routine validation work and on new assignments/projects
Must have experience working with equipment used for the manufacture of monoclonal antibodies
Multi-tasks, organized and capable of working independently with minimal or no supervision
Looks for opportunities to assist others and works well in a team environment
Communicates effectively with customers, peers, and management
Demonstrates respect and appreciation for a diversity of perspectives
Maintains professionalism in presence of conflict
Takes accountability for actions, drives results, and learns from mistakes
Practical experience with quality risk management and risk-based validation
Demonstrates excellent organizational and time management skills

System Validation Engineer Resume Examples & Samples

Defining product requirements and building test plans based on hardware architecture specification,
Developing automated tests in C and Python,
Executing automated tests on pre-silicon software models, FPGA emulation and early hardware,
Debugging issues and reporting problems to hardware design teams,
Extending system test automation infrastructure and tools written in Python and Perl

Validation Engineer Resume Examples & Samples

Specify test cases and test scenarios based on requirements, user stories or specifications
Identify issues - raise, evaluate and document them until resolution
Maintain the system test cases and test data
Report and track test status and test coverage

System Validation Engineer Resume Examples & Samples

Knowledge of Computer System Architecture
Understanding of a subsystem HW/SW stack, including the silicon, all onboard HW components and connectors and devices, drivers, and applications
Experience with C and/or C++ programming, Python
Ability to independently read specifications, identify interesting test cases, document them, and implement them
Experience with debug of Intel chipsets and/or CPUs
Knowledge of and experience with logic analyzers, oscilloscopes, protocol analyzers, in-target probes(ITP) and Lauterbach (LTB)
Excellent technical and problem solving skills
A team player with good organizational and/or planning skills and solid verbal and/or written communication skills
Highly motivated, curious, and have good lab skills (proper tool use, detailed note taking), and be keenly interested in finding and resolving silicon failures

Senior Validation Engineer Resume Examples & Samples

Development and execution of validation documents including but not limited to: SIA, CIA, FAT, SAT, CV, IQ, OQ, PQ, PV, FSR
Performs validation document review and approval
Responsible for validation procedure and template creation and improvement
Writes validation deviation investigation
Develops validation plans
Provides audit support – customer/regulatory /corporate, etc. as needed
Excellent written and oral communication and leadership skills
Complete understanding and application of principles, concepts, practices, and standards within discipline

Validation Engineer Resume Examples & Samples

5+ years of Engineering experience
Solid Data Analysis experience
Experience with process validation on medical devices
Microsoft Office/Suite proficient
Degree in Engineering and/or Science
Knowledge about endotoxins
Experience with Statistical Analysis tools, such as Minitab

Senior Validation Engineer Resume Examples & Samples

Review and provide expertise on validation and engineering documents, change control, CAPA, and other supporting documentation
Partake in cross-functional and cross-site relationships with Manufacturing, technical support groups, and R&D for root cause analysis, problem resolution and system/program optimization
Collaborate with departments to ensure validation and compliance activities are executed efficiently and effectively, and in accordance with all governing documents and external guidelines
Manage competing priorities and allocate and optimize time to ensure targets and timelines are met
Serve as a subject matter expert (SME) in support of department functions. Develop, mentor, and train personnel and internal customers on relevant business processes
Ensure changes have the appropriate level of technical assessment and approval
Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards
Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business
Contributes to defining and timely achievement of overall project goals
Provides compliant solutions to a variety of problems of moderate to advanced scope and complexity
Interacts constructively with employees, managers and cross-functional peers
May lead a project with a limited scope, but usually a contributor on broader projects
Provides guidance to other Professionals and Technicians
Coordinates quality decisions between different quality and engineering groups
Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs)
Team member helping and interfacing with suppliers to deliver product meeting our quality requirements
Maintains awareness of standards that regulate our industry
Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate
Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management
Ensures compliant documentation related to area of responsibility
Applies basic to moderate Risk Management principles to work
Receives general direction and exercises considerable discretion to own work detail
Recommends possible solutions
Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight
Review of existing documents (procedures, WI’s, etc.) for accuracy, robustness, and compliance
Do risk assessment & action plan for resolving found issues
Implement approved action plan related to existing or missing documents
Review of existing documents (FRS, CQ, IOQ, Protocols, and Reports) for accuracy, robustness, standardization, and compliance
CAPA management from initiation through effectiveness check including immediate containment, risk assessment and mitigation, root cause analysis, action plan development and implementation and ensuring of successful effectiveness check phase activities
Key player in global document alignment and restructuring initiative
Uses technical concepts and company objectives to resolve complex issues in creative and effective ways
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
Networks with key contacts outside own area of expertise
Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead)

Senior Validation Engineer Resume Examples & Samples

Lead/Manage validation projects including
Good knowledge and skills in biopharmaceutical and process engineering
Leading or managing of technical projects with an interdisciplinary project team from planning to realization and start up

Validation Engineer Resume Examples & Samples

B.S. Biological Sciences, Computer Sciences or related discipline
Seven to Ten years of experience in a cGMP environment or validation of IT applications, or an equivalent combination of education and experience
Experience in using IT systems in a GMP environment
Knowledge of GMP and EU regulations including 21 CFR Part 11
System Development Life Cycle (SDLC) methodologies
Experience in the implementation and validation of stand-alone IT applications as well as complex enterprise systems such as Oracle LSH, RAVE, and Clinical Systems
Requires demonstrated technical proficiency, creativity, collaboration with others and independent thought
Usage of any Document Management System such as Qdoc, Documentum, Trackwise etc.,
Good technical documentation writing skills
Must be a team player and be conscientious and dependable
Must be able to work independently and adhere to timelines

100

Validation Engineer Resume Examples & Samples

Researches, writes and executes IQ, OQ and PQ protocols for equipment, instruments, utilities and computer systems
Works closely with manufacturing, manufacturing engineering, development and technical support to ensure high quality processes are developed and deployed. Activities include oversight of equipment design verification, equipment qualification, process validation, risk assessment, and FMEA
Works with operations, engineering, quality, and validation teams to determine validation/qualification requirements for equipment, novel technologies and newly designed process equipment and processes
Works with operations and facilities to develop SOP’s that meet all applicable regulatory requirements
Researches, writes and executes environmental protocols using Kaye Validator and data loggers
Researches and writes periodic reviews for all qualified items including software systems
Drives a systematic approach in problem solving and process improvement using quality engineering tools including, but not limited to; Six Sigma, DMAIC, Statistical Process Control, and Design of Experiment to prevent adverse product safety and performance
Works with appropriate parties in providing corrective and preventive actions based on sound engineering analysis
Reviews and ensures all process, material, and procedural changes are engineering sound and in compliance to all FDA QSR/cGMP, ISO, and Quality Policies of the company
Reviews and ensures all qualification and validation documents are in compliance with all applicable regulatory requirements and Quality Policies of the Company
Provides manufacturing systems expertise, knowledge, and leadership in support of production
Meets deadlines according to agreed timeframes and communicates adjustments as needed
Communicates clearly with internal and external clients, both verbally and written
Demonstrates flexibility in organizing work and priorities
Clear understanding of related SOPs, cGMPs and as necessary to accomplish daily tasks
Adheres to company policies; communicates clearly with internal and external clients, both verbal and written
Willingness to contribute to team activities; demonstrates flexibility in organizing work and priorities
Good organizational skills relating to management of associates daily activities
Problem Solving Skills and decision making skills to identify and solve work related issues

101

Validation Engineer Resume Examples & Samples

Post-secondary education in Electrical/Mechanical/Mechatronics Engineering, Physics or Applied Sciences
Good understanding of product reliability and environmental qualification concepts
Minimum 3 years’ experience in a Mechanical/Reliability test laboratory
Proficiency in project management skills: requirements management, schedule and budget tracking, risk and change management
Working experience with MS Project
Strong MS Office skills
Excellent communication and interpersonal skills. Must be able to communicate verbally and in writing complex technical issues in a clear, concise and persuasive manner, adequate for technical and non-technical receivers
Ability to read technical drawings such as electronic hardware schematics, mechanical assembly drawings, refrigeration diagrams, AC equipment power schematics
Experience with using hand tools, test lab equipment (ovens, chambers, vibration system, power supplies, oscilloscopes, DMM), machine shop and metrology equipment
Automotive experience is an asset
Experience with ISO9001 and ISO17025 is an asset
Supervisory experience is an asset
Driver license

102

Validation Engineer Resume Examples & Samples

Work cross functionally to develop and execute validation plans
Generation of design specifications as well as other engineering-related documentation to support facility / utility qualifications and commissioning
Preparation and execution of protocols for validation of HVAC, environmental monitoring, utilities, clean rooms, and cold storage
Develop and defend rationale for protocol design, sampling requirement, and acceptance criteria using industry accepted standards
Compile and analyze validation data and prepare reports
Investigate and troubleshoot problems which occur during qualification and determine solutions
Assess impact of change control to qualified systems to ensure a state of compliance is maintained
Develop and coordinate schedules in conjunction with the other functional groups and vendors
Lead continuous improvement and sustaining efforts to improve effectiveness of validation procedures
Requirement for excellent communication skills and the ability to interact with cross-functional groups at all levels
Foundational understanding and practical experience with FDA cGMP regulations and requirements for facilities and utilities for medical device manufacturing
Establish and maintain cross functional relationships with manufacturing, engineering, quality control, development and regulatory for validation optimization and support of a successful facility validation program
Experience with sustaining and validation of environmental monitoring and control systems (BMS / EMS)
Ability to manage competing priorities/projects and maintain tight timelines

103

System Validation Engineer Resume Examples & Samples

Strong experience with automation, networking processors, test database, product QA, data analytics
Enterprise wireless networks require a very strong understanding of L2 & L3 networking
The candidate must possess good knowledge of wired and/or wireless networking in general

104

Validation Engineer Resume Examples & Samples

Degree in Science, Engineering or related area
3-4 years experience working in a Pharma/Biopharma/Healthcare manufacturing environment
Competent technical knowledge of facility/utility/equipment/process/cleaning/computer systems validation for solid oral dosage and sterile manufacturing facilities
Capable of troubleshooting validation issues associated with projects, process development and technical transfers etc
Application of risk-based approach to validation
Knowledge of industry and regulatory requirements for sterile and non-sterile facilities and processes
Understanding of relevant quality and compliance regulations
Effective project management skills
Detailed knowledge of quality management systems
Good communication skills at organisation, team and individual levels
Ability to use statistical software tools e.g. Minitab packages an advantage
Awareness of safe working practices

105

Validation Engineer Resume Examples & Samples

Bachelor’s Degree in engineering, science or related field with a minimum of 5 years of relevant experience OR Associates degree in engineering, science or related field with a minimum of 11 years of relevant experience OR 17 years of relevant experience with no degrees
Bachelor’s degree highly preferred
Working knowledge of GMPs
Experience taking rinse and swab samples for cleaning validation
Validation using risk based approach (FMEA, PHA, etc)
Ability to read/interpret engineering drawings and design documents
Development of project execution plan and management of small to medium size projects
Must be people oriented and a team player
Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio
Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements
Investigation/troubleshooting validation problems

106

Validation Engineer Resume Examples & Samples

Assure compliance of validated systems for GMP and GLP facilities
Ensure adherence to worldwide regulatory requirements and corporate standards
Write and execute validation protocols (DQ, IQ,OQ,PQ,RQ, PV) with little to no supervision as well as to write comprehensive final reports containing thorough resolution of protocol discrepancies. Temperature mapping protocols are a primary focus
Provides technical assistance to less experienced technicians/engineers
Work as part of a team to ensure that validation activities are completed on time and correctly
Working knowledge of applicable US and worldwide regulatory requirements (e.g. GMP, GDP)
Ability to develop protocols using design documents and user requirements
Ability to manage small to medium size projects
Ability to perform basic statistical analysis of validation test results
Proficient in use of GE/Kaye Validator 2000 and/or wireless data logging systems
Ability to read/interpret engineering drawings (e.g. P&IDs, PFD’s)
Investigation/troubleshooting system failures

107

Validation Engineer Resume Examples & Samples

Coordinates and completes validation tasks in support of new and existing equipment, facility, and utility qualifications as well as cleaning validations
Prepares and reviews validation documentation
Analyses validation data
Supports Validation Engineers on project teams
Participates in risk assessments in support of validation activities
Familiarises and maintains knowledge of current industry practices and relevant pharmaceutical regulations
Acknowledges personal responsibility for tasks
Demonstrates accountability for the delivery of tasks assigned and the competent execution of these tasks
Works with guidance to develop knowledge and skills
Work on own with guidance once competent on tasks

108

Validation Engineer Resume Examples & Samples

Create, revise, and execute Master Validation Plan as required
Lead and further develop the Validation program and strategy in conjunction with Engineering/Facilities Manager
Apply and continue to develop Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
Work closely with Engineering to develop, coordinate and execute Validation documents and strategies
Author supporting Validation documentation including Impact Assessments, Validation Plans, User Requirement Specifications, and Design Qualifications
Perform Risk Assessments (FMEA) and other mitigation strategies on equipment, processes, and facilities
Create and further develop Qualification test methods for a wide range of different equipment, systems, and processes
Author, execute, perform, and summarize Qualification and Validation activities (FAT, SAT, Commissioning, IQ, OQ, PQ, PV, CSV)
Develop, oversee, and execute the annual periodic review process
Perform technical periodic reviews, interpret data for equipment/process performance, identify potential gaps, and determine resolutions to meet a qualified state
Manage and execute decommissioning activities for retired or end-of-life equipment
Author/revise SOPs related to validation/qualification, operations, engineering, and facilities
Represent Validation in cross-functional team meetings/projects as required
Effectively communicate with Leadership and all departments regarding Validation activities
Conduct root cause analysis, deviation resolution (CAPA), and effectiveness checks for validation, engineering, and facilities exceptions
Organize, maintain, and archive all validation documentation
Plan, formulate, and manage all aspects of small Engineering and Facilities projects including planning, vendor management, installation and qualification/validation
Lead and/or participate in other Engineering projects as assigned
Applies Good Manufacturing Principles in all areas of responsibility
Play an integral role in Practical Process Improvement (PPI) program
Bachelor’s degree in Engineering (or related major) from an accredited college or equivalent combination of education and experience
2-5 years previous experience in a validation role is strongly preferred
Validation/Qualification experience in a regulated industry (GMP environment is a plus)
Good understanding of the mechanical concepts related to the operation of pharmaceutical packaging/manufacturing and facilities equipment
Must be able to effectively communicate with internal and external clients at all levels of the organization
Must have the ability to work independently and/or in a team setting with little supervision
Computer System Validation experience is preferred
Ability to multitask and plan/execute several projects simultaneously
Ability to meet deadlines and work under pressure in a fast-paced environment
PPI/Lean Manufacturing/Six Sigma experience preferred
Knowledge of common test equipment used in qualification is preferred
This position works primarily in a Production environment. Must have the ability to occasionally lift up to 50 lbs. Some pushing, pulling, bending, and reaching may be required. Will be required to work in a refrigerated environment on occasion
Up to 20% Travel

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Validation Engineer Resume Examples & Samples

Assists in developing and implementing the validation plan for new and existing facilities
Assists with updates to the Validation Master Plan
Ensures that existing equipment and utilities are sufficiently qualified
Streamlines qualification protocols and generation process
Generates and performs qualification protocols and produces validation reports
Assumes responsibility for aspects of the calibration program on an as needed basis
Improves and tracks the revalidation program
Encourages and suggests process improvements
Completes other tasks as assigned
Knowledge and understanding of document control, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements
Bachelors of Science degree in a related science or engineering field
Minimum of five years in a biomanuacturing operation in a manufacturing, engineering or quality role with at least three years of hands on validation experience
Working knowledge of temperature mapping equipment (e.g. Kaye Validator)
Strong working knowledge of cGMP regulations and ICH guidance regarding validation policy and have sufficient experience with manufacturing equipment and utilities to understand how to design efficient qualification protocols
Ability to work effectively and independently to ensure that validation programs are completed on time and with efficient use of resources
Ability to work effectively in a matrix organization, borrowing and directing resources to supplement his or her effort to complete validation work
Must understand technical oral/written English
Project and time management skills
Bachelor’s Degree in a related science or engineering field
Knowledge of 5S, Lean manufacturing
Line management experience, experience generating validation policy, project management
Prior experience in a small biotechnology company or CMO environment is beneficial
Experience with single-use systems is preferred

110

Validation Engineer Resume Examples & Samples

Manage instrumentation schematics (Fuel, Air, and Lube)
Manage instrumentation location additions to the DMU
1-4 years experience

111

System Validation Engineer Resume Examples & Samples

Design and implement system validation test cases based on hardware, device and product requirements
Set up and maintain automated system integration and validation test benches
Architect and scope infrastructure requirements based on test cases and production functionality
Analyze and investigate the root cause of any failures on the test bench
Provide reports on the health of the product/device from a systems point of view-Foster growth within junior members of the team
Degree in Electronics/Computer Engineering or Computer Science
7+ years of system validation experience
Ability to work in a fast paced environment with changing priorities
Must have strong verbal and written communication skills
Experience working in cross-functional teams Dev, QA, Systems Engineering, etc
Must have working experience with reporting or automation/test frameworks e.g. Nose, USTAB, Robot Framework-Fluent with Linux and Windows environment
Familiarity with Zephyr & Android OS is an asset-Experience with tools like Jenkins, JIRA and HP ALM is an asset
Leadership experience is an asset-Familiarity with agile work flow is an asset

112

Validation Engineer Resume Examples & Samples

21 CFR Part 11 experience
Experience as a Verification and Validation Engineer for 3+ years
Strong knowledge of validating products based on SaaS, cloud-based technologies
Detail oriented and meticulous worker
Good organizational skills in recording test results
Strong belief in quality compliance and following rules
Knowledge of FDA regulations required to test medical products
Cloud, Virtualization, KVM, VMWare
Integration test frameworks such as Cucumber, Selenium
Databases (relational and other; DB2, Cloudant, etc.)
Knowledge of scripting and integration test frameworks is a must
Prepared, reviewed, executed and summarized validation protocols
Served as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention
Provided validation support for the review to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control
Experienced in Software Development Life Cycle (SDLC) Waterfall and Agile methodologies, Manual Testing, White Box and Black Box Testing, Validation and Verification testing
Experienced in System Performance, Unit, Functional, Regression, Integration and User Acceptance Testing
Participated in writing and implementing Test Plans, Test Cases and Test Scripts/Protocols and Traceability Matrix. Executed Test Scripts/Protocols and documented Test Results. Edited and re-tested Test Scripts/ Protocols and signed off (Pass/Fail)
Participated in Requirements gathering, Code Reviews/ Walk Trough
Hands-on experience in Automated Test Tools
Created defect tracking (manual repository), maintained and updated defect statuses and timelines
Exposure in Risk Assessment and Testing Methodologies
Exposure to Protocol Creation, Execution –IQ, PQ
Complaints Investigation for Medical Device (CAPA)
Exposure in FDA Regulations – GMP, CGMP, GAMP, GXP, QSI, 21 CFR Part 11 and CFR Part 820, ISO 14971, Risk Assessment for Medical Device, ISO 1345, IEC 62304 – International Standards (Europe and US) and IEEE, SEI, Six Sigma and other ISO standards and regulations
Discover what you can make of this moment. Embark on the journey with us at IBM Watson Health

113

Validation Engineer Resume Examples & Samples

Bachelors of Science degree in Electrical, Mechanical, or related Engineering
Minimum 3 years experience in Engineering, or related field
Minimum of 1 year experience with Matlab and / or SAS experience
Analytical skills related to wind turbine performance
Ability to effectively communicate solutions to peers
Ability to manage multiple development needs
GB Certification (GE Employees only)
Working knowledge of Wind Turbine Generators
Knowledge of Wind technology and the available options to improve performance in an aftermarket setting
Proven strong interpersonal skills with the ability to influence stakeholders at all levels of an organization
Proven success working with external customers, including the ability to find customer value
Proven success embracing and leading change initiatives

114

Validation Engineer Resume Examples & Samples

CQV for equipment in one of the following areas associated with the manufacturing of biologics drug substance
Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9)
Problem solving ability and excellent oral and written communications skills
Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)

115

System Validation Engineer Resume Examples & Samples

3 plus years of experience and proficiency coding with object oriented (I.e. C/C++) and scripting languages (I.e. Perl/Python) in a Linux based environment
3 plus years of experience working with PC architectures, operating systems, software life cycle and hardware validation methodologies
2 plus years of experience with debugging and problem solving skills
Strong communication skills (oral & written)
Demonstrated ability to communicate with a high level of technical understanding
Self-motivated with the ability to work well within a team

116

Senior Validation Engineer Resume Examples & Samples

Ensure Validation Plans and strategies are in alignment with MSD's global policies, procedures and guidelines and external regulatory requirements, and European and International standards
Responsible for Sub-System Ownership for CH35, and provide Support to other Sub-System Owners which overlap in the implementation of changes and system improvements
In partnership with Quality, Sub-System Owners and Technical Operations, develop sterilization re-validation programs, as appropriate
Accountable for compliance of the site sterilization validation program via documentation completion, risk assessments, proactive identification of risks /issues, review of protocols and reports, closure of preventative and corrective actions, and participation in audits and inspections
Participate on investigation teams in the event of adverse sterilization validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring validation expertise and strong analytical and systematic problem solving skills
Ensure alignment in sterilization validation approaches across the MSD Network, taking an end-to-end viewpoint to ensure successful and reliable product supply
In collaboration with the Product Teams, development groups (e.g. BMSC) and Biotech Technical Operations (BTO) Process Leads, support sterilization validation needs to meet regulatory expectations and supply timelines
Facilitates in problem solving & risk assessment (FMEA) projects/meetings
Develop meaningful validation metrics/trending to enable continued drive for reliability and efficiency
Academic degree/PHD in life sciences (Biotechnology or related) or comparable level through experience
At least 5 years of validation/ manufacturing experience, in a GMP setting. Preference for experience in biologics manufacturing (cell culture, purification)
Proven strong scientific, project & people management skills
Strong communicator and ability to build bridges between groups and organizations. Ability to create a team spirit
Knowledge of GMP guidelines and global validation expectations
Willingness to certify for or possessing Six Sigma Green Belt or Black belt degree
Passion for Lean and Continuous Improvement
Customer focused, process oriented and data driven
Good command of writing and speaking in Dutch and English
Percentage in service at least 90%

117

Validation Engineer Resume Examples & Samples

0 Job Purpose
0 Principal Accountabilities
5+ yrs experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business
Equipment and process validation essential
Sterile filling processes and equipment ideal or Pharma/healthcare environment
Experience in Process Performance Qualification protocol and report generation
Good understanding of Regulatory requirements and experience in writing filings
Quality risk management knowledge/experience

118

Validation Engineer Resume Examples & Samples

5+ yrs, considerable experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business; in a GMP manufacturing setting. in a healthcare/GMP manufacturing setting
Experience in developing and executing cleaning validation strategies
Temperature mapping, Closed Container Integrity and Shipping validation knowle

119

Senior Validation Engineer Resume Examples & Samples

Cell bank
API/Bulk drug substance
Drug product formulation and aseptic filling/tableting
QC testing
Inspection and packaging
Shipping

120

Validation Engineer Resume Examples & Samples

Work with a multi-disciplinary team for validation using a science and risk based approach
Write and execute validation protocols (DQ,IQ,OQ,PQ,RQ,PV) with little to no supervision as well as write comprehensive final reports containing thorough resolution of protocol discrepancies. Temperature mapping protocols are a primary focus. Provide on-site support for Genzyme and Sanofi sites. Provide PV support at CMO’s
Provide QC lab validation review (LEQ)
Provide technical assistance to less experienced technicians/engineers
Work as part of a team to ensure that the validation activities are completed on time and correctly
Develop Validation Plans for small to medium size validation projects, qualification and validation of equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes
Ensure assigned requalifications are completed on time
Write and/or revise global validation documents (VTM,VTS, practices)
Review validation protocols, reports, data, plans, change controls
Proficient in use of GE/Kaye Validator 2000, and/or lives wireless sensors
Bachelor's degree and 8+ years or Masters and 7 years, (or High School degree with 15+years’ experience) of hands-on validation experience in Biotech, Pharmaceuticals or Medical Device operations, including protocol development and field execution
Ability to perform basic statistical analysis of validation rest results
Strong technical writing and verbal communication skills
Demonstrated success working across organizations and sites in highly matrixed/team environment
Ability to read/interpret engineering drawings (e.g P&IDs, PFD’s)
Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio

121

Validation Engineer Resume Examples & Samples

Finds and verifies design solutions to product and test equipment problems
Coordinates the development of new customer products
Designs test fixtures in conjunction with CAD department
Performs vehicle evaluations (subjective and objective)
Assembles and disassembles transfer cases
Performs inspections on all components for wear and durability
Works with Technician to conduct testing on transfer case components
Writes test equipment programs
Writes test reports relating to the outcome of tests performed
Special Assignments - Responsible for support and completion of special assignments as required. Design Release Engineer for component requires analytical abilities
B.S. Mechanical Engineering required
Good follow thru skills with the ability to coordinate projects from start to completion

122

Validation Engineer Resume Examples & Samples

Take part in AWD ECU customer requirement and software requirement review
Create validation test plan and test cases according to customer requirement and software requirement
Carry out validation test and generate test report
Test result analyzing and tracking
Support ECU hardware supplier for hardware validation
AWD system integration test and calibration
Verify AWD system function in customer vehicles
Complete AWD system integration test report
Develop auxiliary testing tools
Responsible for development of test bench and wire harness
Develop test script for automation test
BS – Electrical Engineering, Computer Engineering or Automotive Engineering
Plus minor or other training in electrical/mechanical engineering (preferred)
Minimum of 2 years of automotive engineering experience (required)
Experience with working with Automotive OEMs (preferred)
Experience working with Vector CAN tools (required)
Knowledge of CAN diagnostic/network management related spec (required)
Excellent English skills (required)
Experience of Vector CAN tool script language (CAPL) (preferred)

123

Validation Engineer Resume Examples & Samples

Review, preparation and approval of SOPs, qualification protocols, deviations and change controls
Conduct validation activities in accordance with local policies and procedures and in compliance with applicable regulations, global policies and EHS requirements
Provide validation expertise, technical support and knowledge to site cross functional teams
Preparation, review and approval of risk assessments for equipment and processes
Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project
Review validation documentation from contract vendors to ensure that company requirements are met
Present validation systems at internal and external audits and support quality assurance programmes
Minimum of a Diploma in a Science/ Engineering or related discipline
2-4 years’ experience in a Technical/ QA/ Validation Role within the pharmaceutical industry or a similar operating environment with in-depth knowledge of validation processes
Experience in sterile processes will be considered a distinct advantage
Knowledge of Pharma/Medical product manufacturing, especially sterilisation processes and/or filling operations
Ability to understand manufacturing processes

124

Validation Engineer Resume Examples & Samples

Analyze and summarize the results of various qualification activities using valid statistical practices within the Engineering Quality System
Assist or lead in the creation and qualification of test methods, DOE’s and other activities that determine the systematic suitability of a product
Develop and communicate expectations for quality performance, continuous improvement, quality systems, and process controls infrastructure for critical sustaining parts and new products
Develop and execute IQ, OQ and PQ protocols to ensure compliance with the Engineering Quality System and customer requirements for product, processes, facilities, software and equipment within the facility and / or contract manufacturer
Develop and execute the Validation Master Plan, covering internal and external operations and key processes
Develop and execute Validation programs for internal and external operations
Other tasks as required by management or as needed to support business continuity
Participate in, or lead, cross-functional teams as needed to transfer products between Plants or to contract manufacturers and to implement or execute programs and that will assist with those transfers
Participate in, or lead, cross-functional teams as needed to transfer products from development to production and to implement or execute programs and activities that will assist in the development or improvement of products and processes
Refine standard validation practices to ensure that all practices are efficient and current with industry and regulatory requirements
Review documentation, manufacturing practices, engineering change orders, and procedure changes for quality requirements and compliance with the engineering quality system
Review existing validation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner
Support project teams to assist the qualification of process changes
Train and coach local plant validation resources in order to ensure knowledge transfer, understanding and timely V+V activities

125

Senior Validation Engineer Resume Examples & Samples

7-10 years’ experience in pharmaceutical/biotech operations
Minimum 5 years’ direct/ hands on experience with validation of equipment, computerized systems, utilities, and facilities
Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required
Technical expertise in biotech unit operations, ability to handle multiple projects at one time
Working knowledge of processes in fermentation, purification and/or formulation required
Strong leadership, organizational planning, and project management skills
Excellent interpersonal effectiveness and communication skills (written and oral)
Ability to work with a cross functional team to achieve expected results
Proficient in MS Word, Excel, and Project
Physical Requirements-Ability to lift 20-30 lbs and stand for an extended period of time

126

System Validation Engineer Resume Examples & Samples

Minimum B.S. in Electrical Engineering / Computer Engineering / Computer Science with 3-5 years of working experience in the following areas
System validation and/or verification/AV and/or post silicon validation
Scripting in BASH, Python, Ruby or similar runtime scripting languages
Familiar with Networking protocols - Ethernet MAC and TCP/IP
Familiarity with Linux drivers and/or Linux kernel
Familiarity with Virtualization
Curiosity, creative thinking and strong problem-solving skills
Self-Motivated and Initiative to do things
Able to work with tight schedule flexible, dynamic program/project needs
Able to pay attention to details and look in to adjacencies
Proven experience in development of Windows and Linux Network Drivers. Software/Hardware interfaces and interaction and Socket Programming understanding
Candidates with emulation hardware understanding and validation using ZEBU, Veloce, FPGA env are preferred

127

Validation Engineer Resume Examples & Samples

Strong Experience in Computer Systems Validation (CSV) within the Pharmaceutical industry
Schedule and plan equipment and process qualification workload to meet approved schedules
Handle multiple projects and be able to work independently as required
Develop GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrix, system, and Validation reports, SOPs, Change Control Documentation, and Risk assessment/FMEA reports as required
Establish critical parameters, plan, design, and implement validation projects and protocols
Ability to author, execute, and thoroughly review complex protocols
Coordinate validation activities with other departments
Stay current with industry qualification trends through FDA, ISPE, EU and bench marked companies
Consult, coordinate, cross-function with various personnel within the company and externally
Have the ability to problem solve with minimal oversight, including conducting research to aid in the resolution of issues that arise
Train and mentor other Validation personnel as necessary
Determine and acquire necessary supplies and equipment for validation activities (Planning)
Administer the site Change Control Program
Make decisions representing QA in multi-functional teams
Plan and assist with the global serialization project
Familiarity and experience with TrackWise, LIMS, ComplianceWire, JDE, GAMP is desirable

128

Validation Engineer Resume Examples & Samples

Handle multiple projects and work independently
Write, execute, and review complex protocols
Previous experience in the pharmaceutical industry with a manufacturing background
Advanced knowledge of cGMP’s and regulatory requirements as they relate to IQ/OQ/PQ/VQ’s

129

Validation Engineer Resume Examples & Samples

Ensuring a high level of conformance to the established quality systems (principles of ISO 9001 and cGMP)
Developing, executing, managing and continuously improving the site master validation program, the calibration (metrology) program and engineering quality assurance systems
Work closely with QA and senior manufacturing staff
Assisting with Engineering and facilities responsibilities
Interfacing with operational teams in resolving quality procedural and validation variances, as required
Conceiving/leading/managing/participating in quality improvement initiatives associated with Validations and Engineering
Maintaining a high level of cost stewardship
Actively participating in customer and regulatory site audits, as required
Champion the Engineering Validation function as a team and service based organisation in support of operations at the shop-floor level
To carry out any reasonable tasks requested to improve the Company’s operations
Bachelor degree in a scientific/engineering discipline or equivalent
Related experience as a validation technician in a rigorous cGMP or similar compliance environment, preferably in the biopharmaceutical, pharmaceutical industry, or diary industry
Strong production process and/or manufacturing engineering background, with experience in process validations preferred
Technical knowledge base in cGMP validation concepts and techniques
Highly self-directed and results focused
Excellent team and interactive skills
High level of internal and external customer focus and responsiveness
Experience in a cGMP environment

130

Validation Engineer Resume Examples & Samples

Establish necessary validation documentation for new equipment as user requirement specifications and validation plans
Establish overall plans for calibration, qualification and maintenance
Responsible for calibration and qualification of critical instruments
Coordinate external support
Establish and maintain standard operating procedures (SOPs)
Report and handle deviations in TrackWise
Suggest and document improvements and changes
Participate in development projects
Interact with specialists in other parts of the organization as process development, QA/QC and production teams
Maintain high level of quality through documentation
Support the Facilities & EHS team with other task as necessary
Higher level of education as BSc or MSc in Engineering
Experience from validation, calibration and maintenance of production and sterilization equipment, including practical work and documentation
Like to take initiative and at the same time be part of a team
Structured and self-driven
Fluent in a Scandinavian language, as well as strong English skills

131

Validation Engineer Resume Examples & Samples

Requires ability to communicate effectively verbally and in written form
Ability to prepare reports using Excel; knowledge of Windows, Word and Access preferred
Knowledge of Universal Precautions, general laboratory and quality assurance/control preferred
Valid driver’s license and good driving record if required to travel to other locations
Requires a High School Diploma; Associate’s degree in Engineering/life science field preferred
Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries
Prefer experience with Current Good Manufacturing Practices (cGMP)
Prefer ability to perform NIST traceable temperature and humidity measurements with a variety of temp/humidity measurement devices
Prefer Validation experience with Cleaning Validation; Equipment Validation; Critical Utility Systems Temperature Mapping/ Kaye Validation platform/ Controlled Temperature Units/ Freezers/Data Loggers
Prefer Qualification experience with IQ/OQ/PQ protocol development/writing/execution; GAMP; Facilities; Utilities/HVAC; Process Equipment; Final Reports
Prefer basic knowledge of refrigerator and freezer operation and temperature distribution patterns in storage spaces

132

Senior Validation Engineer Resume Examples & Samples

2 years experience in Computerized System Validation
2 years experience in manufacturing/manufacturing science and technology/technical development/Quality. Preferred: 6 years manufacturing experience
Thorough understanding of manufacturing processes and related process equipment
Advanced in writing and reviewing protocols and technical reports

133

Validation Engineer Resume Examples & Samples

Over The Air (OTA) validation engineer
Work with Calibration Engineers and DREs to obtain appropriate software archive(s) for OTA validation activities
Engage VVEs, System Bench Leads to reserve/schedule appropriate vehicle or bench test properties, respectively
Develop & Execute test procedures that comprehend OTA requirements and functionalities
Execute validation plans for the subsystem at bench and vehicle level
Analyze the vehicle portfolio and associated interfacing subsystem rollout (clusters, BCM, Radio, ECC, ECM, VICM, etc.) to develop a high level test matrix that ensures that all vehicle/component combinations are tested
Track & Plan future OTA validation based on present and future ECU availability
Execute testing to developed test methods that validate system requirements of OTA targeted ECUs
Track hardware and Software changes to Telematics’ interfacing ECUs as they relate to OTA
Provide and report status of testing and validation activities
Timely document all anomalies using existing documentation tools (ESIM/PRTS)
Follow issue resolution from issue origination thru verification, closure, and monitoring
Update component / subsystem scorecards to properly status OTA validation status
Work with engineering functions, suppliers and others to implement cost reduction items or product improvements
Attend PDT's when required and contribute validation status
Anticipate and communicate validation roadblocks/challenges
Develop and implement new test methods to improve quality/efficiency (automation, etc)
BS Electrical Engineering and minimum 5 years of validation experience
High level of analytical ability to understand the operation of complex combinational and sequential systems
Ability to manage multiple project assignments and switch between tasks as timing and resources dictate
Self motivating to achieve results on time with minimum supervision
Ability to work independently and with others
Experience with automotive electrical systems
Experience with telematics related components and functionality
Experience with automotive serial data protocols (CAN, MOST, Ethernet, etc)
Experience with automotive serial data tools (Vehicle Spy, Mocha, etc

134

Validation Engineer Resume Examples & Samples

Educational requirements for this position are a BSEE/CE minimum, MS preferred
5-10 years’ experience in ASIC Iogic verification and strong software skills
Experience using 1 or more of the following Ianguages: System Verilog/Verilog, Perl, C/C++
Candidates should also have experience with RTL simulators, VCS preferred
Experience with hardware emulator such as Synopsys Zebu, Cadence Palladium or Mentor Graphics Veloce
Experience specifying and developing test bench components, specifying, developing, and debugging functional tests, and experience specifying, implementing and analyzing functional coverage
Strong debug abilities
Good interpersonal skills and the ability to work in a highly cooperative team environment across many time zones are also desirable
A strong background specifying and developing random test environments is also desired.Search Jobs US

135

Validation Engineer Resume Examples & Samples

Must have either a BS or MS in Computer Science, Computer Engineering or Electrical Engineering,
Minimum 2 years' experience with programming in one of the languages: C, C++, C#,
Methodical problem solving skills,
Fluency in Polish and very good knowledge of English
Strong understanding of Intel server platform architecture, including server I/O and manageability interfaces SMBus, IPMI, networking, PCI Express, SPI etc.,
2+ years of relevant firmware development/debug experience,
6+ months experience with building models in WindRiver SIMICS,
Experience in distributed and parallel programming in C,
Experience in Python programming

136

Validation Engineer Resume Examples & Samples

B.S. Degree in Engineering or scientific discipline or 5+ years validation experience in the pharmaceutical or medical device industry performing the tasks listed above
Influence and coordinate activities of personnel over which he/she has no direct authority
Effectively communicate with all levels of the organization from the General Manager to the production operators
Must be proficient with Microsoft Office
Travel will be required to support multiple projects

137

Quality Validation Engineer Resume Examples & Samples

Bachelor’s Degree in Engineering, or Science plus 5 year experience in a related field
Validation experience in the areas of automation, packaging, utilities and/or facilities is desired
Experience working in a fast paced manufacturing environment
Experience with lateral flow devices a plus
Knowledge of medical device industry preferred (GMP/QSR and ISO 13485)
Ability to multi-task and be flexible as priorities change
Organized and high level of attention to detail
Forward thinking

138

Validation Engineer Resume Examples & Samples

BS/BA
Support all aspects of the Validation Life Cycle in Manufacturing from design through operation and improvement as required
Assist in administering the Computer Validation Program for the site, including the author/review/approval of Computer Validation Master Plans, Process Control Installation/Operational Qualification protocols, and alarm acceptance testing protocols, computer acceptance protocols and maintenance of computer systems in accordance with corporate and departmental procedures
Provide key technical review for the Marietta Site with respect to SOP development and provide technical input for change control in order to assure that site needs are addressed and compliance and industry standards are incorporated
Author, review or revise Standard Operating Procedures (SOP’s) as required
Responsible for the site requalification plan execution and implementation
Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies
Participate on cross-functional teams, including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient. Build and enhance interdepartmental relationships. Implement improvement initiatives with filling/packaging and facility/utility qualification activities
As the site validation representative, present information or answer questions to regulatory agencies during the audit process regarding the validation program and specific validation studies

139

Validation Engineer Resume Examples & Samples

Detailed knowledge of relevant dosage form including liquid and semi solid : unit operation understanding, functionality and criticality of formulation materials and their transformations (e.g. powder technology, colloid science, crystallisation drying and particle size reduction), plant equipment and analytical testing. Awareness of device/packaging processes
Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs (particle science and formulation expertise)
Knowledge of regulatory environment, particularly in markets where product is commercialised
Track record of improving products, processes and trouble-shooting, execution of technical activities including trials and validation activities
Experienced in technology transfer, with an understanding of the product development process
Able to evaluate potential innovative technology areas relevant to product
Thorough knowledge of GMP and EHS requirements
Demonstrated in-depth knowledge of risk management approaches
Able to assess/interpret statistical data e.g. process capability, control charts, DoE, MSA
Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions

140

Validation Engineer Resume Examples & Samples

Working knowledge of cGMP regulations and validation guidelines
Capable of working safely and complying with all safety regulations
Good communication, organizational and team skills
Familiarity with statistical sampling plans
Capable of working independently (and with a sense of urgency when necessary) with minimal supervision
Ability to work on multiple projects, ability to focus on the important projects and flexibility to adapt to changing priorities
Computer skills including Microsoft WORD, EXCEL and POWERPOINT
Computer validation experience preferred
Statistical analysis skills desirable
Green Belt certification or training desirable
Utilizing the GSK requirements and guidelines pertaining to the Validation Life Cycle and with adherence to all applicable Quality, FDA regulations, and Safety regulations, write and execute Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), Process Validations (PVs)/Process Characterizations (PCs), Cleaning Validations/Verifications, assist in spreadsheet validation protocols, Computer Validation (using GSK established methodologies i.e. iQMS), Continued Process Validation (CPV), coordinate validation executions with Engineering, Manufacturing, Packaging, and Quality and produce the subsequent Validation Reports of the executed protocols and perform Periodic Reviews of validated systems
Assist System Owners (Operations, Quality) and Engineering to create User Requirement Specifications (URS) and Functional Specifications (FS), Design Specifications (DS), and other necessary design documentation, respectively, for GSK-St. Louis Systems
Evaluate new equipment i. e. Factory Acceptance Testing (FAT) to ensure the equipment meets User Requirements
Perform statistical analysis on the validation data generated and organize the data in tabular or graphical form
Improve compliance by writing and/or revising Validation and related SOPs
Participate in Operation Excellence (OE) initiatives, cross-functional teams, and special projects as required
Complete internal and external Audit findings as assigned
Ensure quality and compliance in accordance with established procedures and standards of the Quality System
Comply with and support the GSK Environmental, Health and Safety policies and procedures

141

Validation Engineer Resume Examples & Samples

Customer Test Reports: AAM Test Engineers are responsible for writing internal level test reports that contain the basic test result data. These reports are not suitable for the customer for many reasons. For instance, they often include data on set-up parts, fixture issues, and test runs with malfunctions. The internal reports do not make conclusions to test results or how they compare to customer requirements. The customer level test reports need to present a clear picture of the test conditions, part level, & failure mode. It will tie the test run to the customer level requirement and present conclusions regarding the acceptability of the test results
DVP&Rs:During a program, the DVP&Rs are a living document with results being added, timing updates, test additions, etc. The AAM Validation Engineer will be the primary keeper of the DVP&R. He will work with the Application and Test Engineers to plan and prioritize the testing. The main priority will be a thorough validation of the design, but the Validation Engineer will also be tasked with reducing the cost and lead time of the validation plan
Test Orders:The AAM Validation Engineer will work with the AAM Application Engineers to develop a plan for writing Test Orders. At the completion of a Test Order, it is often standard procedure to write a CML Materials Lab request to document the sample’s material & its failure mode. In addition to the CML, additional post-test information such as detailed photos or NVH qualification may be required
DCLA (Duty Cycle Life Analysis): Currently, the AAM Test Engineers perform the DCLAs but there is no consistent reporting of conclusion linking a DCLA to a particular Test Order, particular set of Road Load Data, and a particular customer requirement. The AAM Validation Engineer will be responsible for making these connections and presenting clear concise documentation supporting conclusions
Program Role & Scope: The AAM Validation Engineer will be responsible for validation on multiple parts on a particular program. For example, on the Zeta program, the Validation Engineer will be responsible for the validation on the 195 mm and 218 mm RDMs as well as the 165 mm Front Drive Unit. The Validation will need to ensure consistency in tests and methods across the program’s products. The Validation Engineer will also help to determine the standard tests that will be used to validate different axle components as revisions occur during the program
Validation Prototypes:The AAM Validation Engineer will assist with prototype builds with particular emphasis on the prototypes that will be used for validation. It is extremely important to document the prototype material that is tested. In some cases the validation testing may include limit samples. In others, the dimensional or metallurgical state of the test samples will need to be documented internally or in customer reports
Test Development: Sometimes it is necessary to develop a new test during a program. Sometimes unique tests are required to be developed to replicate conditions or events seen during vehicle usage. They can also be driven by specific customer requirements
Road Load Data Acquisition (RLDA) & Analysis: The AAM Validation Engineer will be involved in determining the vehicle data to be acquired as well as the interpretation and adjustments required to the data once it is available
Supplier Component Testing:Supplier component testing such as will be conducted on seals, bushings, bearings, lube, clutch plates, and gaskets will require oversight & tracking as part of the overall test plan. This also applies to fastener testing which may be performed at a suppler or by an AAM Fastener Engineer
PRTS Response & Customer Validation: The total validation plan includes testing & evaluation at both AAM and the customer. The AAM Validation Engineer will support customer validation which will include responding to test incidents or PRTS issues. Investigation into part usage and test conditions at the time of the incident will be required as well as participation in the post test tear-down, root cause determination, corrective actions, and writing the PRTS response for Application Engineer review

142

Validation Engineer Resume Examples & Samples

Develop validation master validation plans, process flow diagrams, protocols, or standard operating procedures
Prepare qualification designs to include sampling, testing, or analytical methodologies
Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production
Identify deviations from established standards and provide recommendations for resolving deviations
Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards
Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems
Prepare detailed reports based on results of validation and qualification tests or reviews of procedures and protocols
Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies
Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols
Assist in training equipment operators or other staff on validation protocols and standard operating procedures
Communicate with regulatory agencies regarding compliance documentation or validation results
Maintain validation test equipment
Bachelors Degree in Engineering or related science field. Ten years experience in the pharmaceutical or biopharmaceutical industry with 5+ years of hands-on experience
Extensive knowledge of validation requirements for US and EU compliance regulations and industry practices

143

Driveline Validation Engineer Resume Examples & Samples

Chassis Driveline system experience - design, development, test and/or validation
Automotive supplier, Contract Engineer experience, SMT Experience and/or Test Engineer Experience
Familiar with Manufacturing processes
Experience working with GM suppliers or external organizations
Validation Apprentice Certification, Validation Journeyman Certification, Ability to work in PQMS, PRTS, Vis Mock up, E-squared, GSTS

144

Fpga Validation Engineer Resume Examples & Samples

Responsible for Timing Analysis and closure
Responsible for board bring up with interfaces, functional validation and debugging on FPGA/ SoC platforms using Xilinx tool chain
Responsible for Validation environment development and execution
Strong knowledge of complete FPGA/SoC development flow
Experience in post implementation steps such as synthesis, place & route, timing closure of FPGA/SoC based systems
Hands on experience in FPGA/SoC board level testing (board bring up, debugging using Xilinx tool chain)
Hands on experience Xilinx SoC devices with DDR/LPDDR interface
Hands on experience with Xilinx IP’s usage
Hands on experience of Video Interface/ AMBA protocol/Ethernet/PCIe/SPI/I2C/UART peripherals
Good knowledge of scripting languages such as Perl/Python/Shell

145

Senior Validation Engineer Resume Examples & Samples

Develop and maintain the programmatic aspects of the aseptic and process validation function
Lead execution of all aseptic and process validation functions and provide guidance and assistance regarding execution to validation engineers and technicians
Supports validation change control activities
Proficient in Microsoft Office; Word, Excel, Outlook and basic statistical software
Experience executing process validations under the 2011 new industry guidelines
Detail oriented, self-motivated, organized and have the ability to prioritize work
Prior experience in sterile operations
Able to work independently with minimal direction

146

Validation Engineer Intern Resume Examples & Samples

Education: BS in Electrical or related field
Familiar with Lab equipment as DMMS, Oscilloscopes, Power Supplies, etc
Must be self-motivated and able to work in independently and in a team environment

147

Validation Engineer Resume Examples & Samples

1) Very good know how on IC Validation with strong hands on experience of Hardware functional validation
2) Proficient in using the lab equipment’s like Oscilloscopes, spectrum analyser, Thermal chambers etc
3) Hands on experience in NI Labview and its usage on controlling various validation infrastructure
5) Experience in digital and mixed signal automotive designs
8) Should be very good team player
9) Expert in handling validation board related issues

148

Validation Engineer Resume Examples & Samples

Identifying opportunities to revise and improve product design or product performance and implementing these improvements
Participating in cross functional teams to troubleshoot and resolve technical issues in a timely and effective manner
Developing testing strategies and completing analysis of product performance/functional data
Must be well organized, detail oriented and have the ability to plan, prioritize and manage multiple projects effectively
Effective verbal communication is a requirement
Candidate must be able to effectively present information to a variety of audiences
Candidate must also possess excellent technical writing skills
Candidate must be able to effectively analyze data and information
Experience leading cross-functional teams and managing programs is preferred
Candidate must be able to use a variety of software systems to gather information/data as necessary.Search Jobs US

149

Validation Engineer Resume Examples & Samples

Knowledge in python scripting. Comfortable with Automation frameworks, Manual Testing
Knowledge in iDrac testing, AXON framework, Linux scripting knowledge
Executing automation scripts
Validating test results
Integrating test scripts with Validation tools
Debugging test cases

150

Electrification Drive Unit System Development & Validation Engineer Resume Examples & Samples

Develop drive unit hardware to optimize system performance (improve durability/reliability, improve fuel economy, reduce cost)
Perform system modeling
Execute system testing (managing instrumentation and powertrain controls interface)
Define required design features
Work with component engineers to develop design to meet requirements
Lead resolution of identified concerns identified in system testing working with component and vehicle system engineers
Plan and execute required testing to demonstrate drive unit system reliability
Automotive electric propulsion systems experience
Electric motor and motor controller experience
Experience with INCA & MDA software & ETAS hardware
DFSS and Red-X experience
Masters in Engineering related field

151

Validation Engineer Resume Examples & Samples

Act as Subject Matter Expert (SME) on periodic re-validation of commercial product equipment and manufacturing
Possess ability to answer validation questions and interact with various regulatory agencies
B.S. / B.A. in Engineering or Science
Demonstrated leadership and teamwork skills, excellent analytical abilities, excellent written and
Verbal communication skills

152

Validation Engineer Resume Examples & Samples

Experience on the similar position
Train system knowledge (system analysis, railways) : at least 2 years
Required electrical habilitation level (SEP)

153

Validation Engineer Resume Examples & Samples

To succeed at this job, you must have strong knowledge of SQL and database servers (SQL Server, Oracle) and SQL language; strong understanding of web technologies and application servers (such as HTTP, HTML/XML, jboss, IIS, dotnet framework, WCF); API testing (Soap, REST)
It would be preferred if you have previous experience in solution validation, end-to-end testing, and integration
You must have a Bachelor's Degree in Computer Science, Engineering, or a related field. You must have the U.S. citizenship per CFIUS requirements
We are looking for someone with a strong technical background, with a very good analytical mind, problem solving skills, autonomous, able and willing to learn
You must be able to travel up to 30% of the time domestically during the specification and integration phases and for workshops
Apply now before this career opportunity is filled. We look forward to reading your resume!

154

Validation Engineer Resume Examples & Samples

To succeed at this job, you must have a previous experience in software validation and end-to-end testing, good knowledge of validation methodologies and troubleshooting tools (Wireshark, SoapUI…), troubleshooting skills, general knowledge of various software architectures, Windows environment and SQL language
It would be preferred if you haveknowledge of database servers (SQL Server, Oracle); understanding of web technologies (such as HTTP, HTML/XML, WCF…) and application servers (JBoss, IIS), API testing (Soap, REST). Knowledge of PKI (Public Key Infrastructure) and Windows administration (Active Directory, LDAP…) is a plus
We would like someone to join our team who is a strong team-player with proven team development experience and a willingness to adapt to new technologies
We are looking for someone with 5+ years of validation experience, with a strong technical background, with a very good analytical mind, problem solving skills, curious and creative, autonomous, able and willing to learn
You will havethe possibility to grow professionally in the team and in the company

155

Validation Engineer Resume Examples & Samples

Plan, schedule and execute the Design Validation Plan & Report (DVP&R) and Product Validation Plan & Report (PVP&R)
Serve as Test TPL for assigned program(s)
Analyze, document and publish data and test reports to support test plans for internal discussion and review with customer
Provide relevant and timely feedback, troubleshooting and problem resolution information to design engineering
Track, identify, and log all issues that occur during the test phase
Coordinate with manufacturing facilities to transfer pertinent information regarding product testing
Work with test or equipment suppliers to obtain quotes, specify requirements, purchase instrumentation, and develop fixtures for conducting tests within a given budget
Manage dynamometer test facilities including defining test cycles, programming and working with dyno operators to execute test plans
Specify requirements for test equipment, fixtures and scripts
Work with suppliers to conduct testing
Manage test data by appropriately storing and backing up the data
Review customer design requirements
Write test procedures according to customer requirements and document according to ISO standards
Work with the customer and Engineering to get approval and update test procedures
Experience in environmental, mechanical and electrical verification testing methodologies
Replicate problems to determine type/nature and communicate to engineering to help resolve design issues
Excel, MatLab and/or LabView Scriptwriting
Experience with vehicle Controller Area Network (CAN) communication interface
Experience with Vector CANoe/CANalyzer
Thorough analytical and organizational skills
Safety and Quality Mindset
Masters degree in Electrical or a related engineering field
Experience with high voltage a plus
Experience with automotive EMC testing a plus

156

Emulation / Validation Engineer Resume Examples & Samples

Knowledge and understanding of CPU Arch, SoC, Fabric
Knowledge and understanding of Storage and Communication protocols (PCIe, SATA, Ethernet )
Knowledge of Hardware verification concepts and tools (UVM , Coverage Driven verification)
Experience in Embedded SW (Ansi-C, Linux drivers, FirmWare validation)
Scripting language (Perl/Bash/TCl/Python)
Experince with emulation platforms / FPGA

157

Validation Engineer Resume Examples & Samples

5 years pharma/FMCG and practical experience related to validation of equipment and systems; experience writing, execution and review of IQ/OQ/PQ preferably with knowledge of secondary process equipment
Provide key technical review for the project & KL Site with respect to SOP development and provide technical input for change control in order to assure that project/site needs are addressed and compliance and industry standards are incorporated
Responsible for the project qualification plan execution and implementation
Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the project/site participating in validation studies
Participate on cross-functional teams, including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient. Build and enhance interdepartmental relationships
As the project validation representative, present information or answer questions to regulatory agencies during the audit process regarding the validation program and specific validation studies
Other assignments as deemed necessary

158

Validation Engineer Resume Examples & Samples

Facilitate successful team behavior within Quality Systems and across functional areas. Manage relationships externally and internally. Build cross-functional and cross-departmental support, fostering overall effectiveness. Ensure compliance through assisting in audits. Ensure that all validation activities are carried out and reported in a timely manner
Lead and coordinate documentation archiving and the archive itself ensuring that all the stored documentation is managed as defined
Facilitates, encourage and coordinate continuous improvement with respect to validation activities. Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
Adhere to Health, Safety and Environmental Policies, and keep an healthy and safe-conscious working environment, in order to minimize or eliminate risks exposure to personnel, company assets and societal impacts and be in line with or ahead of any applicable Law requirements and Company standards
Masters degree in Biological sciences, Physical sciences, Engineering or equivalent skills through demonstrated experience
3-5 years experience in quality assurance in tobacco, food, pharmaceutical or similar industry and/or 3-5 years experience as a specialist in a relevant area of activity
Advanced knowledge of relevant standards (ISO, GCP, ICH, GMP and GLP)
Well-developed IT skills (Microsoft Project, Excel, Word, PowerPoint, Outlook, Documentum / Score)

159

System Validation Engineer Resume Examples & Samples

Pre-silicon verification and post-silicon system validation
Test case and test automation scripts development and test plan execution
Help to debug system (hardware, software and firmware), provide expert support to internal as well as external customer
Silicon characterization and failure analysis
Bachelor degree and above of computer science or electronic and electric engineering Minimum three years’ experience of hardware development and system verification In consumer/electrical products Familiar with system board design/debugging and usage of lab equipment like Oscilloscope and Logic analyzer Experience of silicon verification, test program development and test plan execution Understand PCI/USB/PCI-E/ETHERNET/SPI bus protocol Knowledge of RTL language, in-circuit emulation and FPGA fast prototyping is an advantage Experience of C/C++ Programming language, Knowledge of XDSL, DSP, ETHERNET switch, and wireless LAN is preferred Team player, very proactive and self-motivated

160

Senior Validation Engineer Resume Examples & Samples

Minimum of a bachelor’s degree in Packaging, Mechanical Engineering, or science related field from an accredited university or college
A minimum of 7 to 10 years experience in the field of implantable medical devices, or package development related experience in a regulated environment
Must have a functional understanding of basic designing, and have a high level of proficiency with reading and understanding device drawings
Experience with ProEngineer, or other related CAD software is preferable

161

Validation Engineer Resume Examples & Samples

Validation empowered representative on cross-functional project teams
Validation Project Manager for cross-functional project teams
Researches governmental regulatory requirements on each assigned project to ensure that each study subject is challenged to meet required specifications
Prepares scientifically sound Validation Study Protocols that incorporate the defined specifications into acceptance criteria and assessment procedures
Schedules the execution of Validation studies with the appropriate department
Prepares detailed, concise documentation dossiers on completed studies that summarize the studies experimental results and specifications and their conformance to defined acceptance criteria
Perform test plans as required by Equipment Change Orders
Maintains close contact with Business development, Engineering, and Manufacturing groups to assure effective communication on challenges and opportunities related to validation
Provides technical support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs as needed
Assists the Validation department in developing policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements
Works directly with management, contract customers, and/or contract engineers
Maintain effectiveness of the Quality System components relevant to this position
A minimum of one year experience in validation within a pharmaceutical manufacturing operation or three years’ experience in pharmaceutical operations is required
Knowledge of cGMPs, pharmaceutical manufacturing methods and validation principles is required
Ability to work independently on multiple projects
Be knowledgeable. Bring experience to the organization. Learn new skills; collect new information. Demonstrate a willingness to share skills and information with others
Demonstrate initiative. Develop ideas, and collect them from others. Continuously seek opportunity. Be detail oriented. Clarify issues, investigate
Full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred
Make sound judgments. Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically
Meet deadlines and work under pressure with limited supervision
Possess and demonstrate excellent verbal, written and interpersonal communications skills
Should be familiar with cGMP and safe work practices
Strong Mechanical aptitude
Works well under pressure and able to prioritize workloads
Demonstrated ability to read, write, and speak clear English

162

Senior Validation Engineer Resume Examples & Samples

Develop and execute qualification/validation protocols and reports for facility, utility, equipment, process, and software projects for the Madison site
Develop plans and project manage validation activities as applicable
Interface with multiple Illumina departments, both internally at Madison and externally at other sites. Provide consultation to other departments performing validation activities as applicable
Provide strategic support for QA Validation Manager
Ensure validation program compliance to FDA, ISO, and Illumina standards

163

System Validation Engineer Resume Examples & Samples

The activities include developing Virtual Platforms, enabling RTL in SLE (Emulator) and FPGA Models, working with SW and firmware teams to bring up entire Virtual/emulation or FPGA platforms for use in RTL Validation, SW/Driver development, Power/performance validation and manufacturing validation
The scope of the work spans all Client, Server and Devices (IOTG, Wearables and Phone/Tablet) segment products
The job is critically important as Intel is ramping up focus on new devices and segments where pre-silicon development is critical part of overall product development cycles
Xilinx/Synopsys/Mentor/cadence Tools Flow HAPS etc
C/C++, SystemC, Wireless, IA, SoC Architecture, UPF and Low Power Flows

164

Component Validation Engineer Resume Examples & Samples

Managing multiple components across autonomous vehicle platforms
Authoring validation requirements for new sourcings and providing corporate Appendices
Participation in Supplier selection process as voice of validation
Working with supplier to create and monitor test plans for environmental, EMC, software, diagnostics and all required validation activities
Tracking progress towards required component testing tied to Global Vehicle Development milestones
Coordinating activities and managing a full test plan including required supplier testing as well as all other testing required to validate component including, but not limited to: applicable regulatory testing, subsystem integration testing, functional safety testing
Interface to program teams and vehicle validation teams for component status
Participation in DFMEAs
Attending cross-functional, commodity specific meeting (PDTs) as representative of validation
Working with the supplier to develop Validation Cross Reference Indices (VCRIs) to ensure all requirements map to appropriate validation procedures
Supporting software change analysis review
Working with supplier quality and plan and implement test procedures during line moves and/or sub-supplier changes
Issue part saleability status in GM part ordering system based on successful completion of all required testing
Communicate, coordinate, and consult with engineering departments, vehicle platform teams and supplier quality
Bachelors of Science in Engineering or
Knowledge of GMLAN or CAN based communication

165

System Validation Engineer Resume Examples & Samples

Provide reports on the health of the product/device from a systems point of view
4+ years of system validation experience
Fluent with the Python scripting language
Familiarity with reporting or automation/test frameworks e.g. Nose, USTAB, Robot Framework is an asset
Fluent with Linux and Windows environments
Familiarity with agile work flow is an asset

166

Validation Engineer Resume Examples & Samples

Generates, revises and executes documentation for validation studies ensuring compliance with QA and cGMP systems
Responsible for generating and executing validation protocols for new equipment, instruments, utilities, computer systems, control systems through commissioning, URS, IQ, OQ, and PQ phases
Responsible for the management of consultants used to support spikes in validation
Assist with contractor audits, supplier audits, pre-delivery inspections and on-site factory acceptance tests when related to validation. This may involve short periods of travel
Responsible for the calibration of equipment supporting validation protocols and ensuring the calibration specifications for the equipment are appropriate
Responsible to participate in both factory and site acceptance testing for new manufacturing and engineering equipment
Required to support the validation schedule within the scope of ongoing projects
Support facility qualification of ISO 8 and ISO 7 classified environments
Support manufacturing, engineering, quality assurance, and quality control for validation related activities
Assist with validation planning and risk assessments associated with validation activities
Resolve CAPA's and change controls related to validation protocols
Execute lyophilizer annual requalification and final package integrity testing
Generate data and reports for the validation system evaluation program
Bachelors or Master’s Degree in Chemical Engineering or other science or engineering field preferred; equivalent combination of education and employment may be considered
9+ years' practical experience with 5+ years relevant experience specific to this position
Ability to read, analyze and interpret common scientific and technical journals. Ability to communicate to a group of individuals through oral and/ or written materials
Knowledge of pharmaceutical manufacturing processes, quality improvements, and efficiency. Strong writing ability required
Knowledge in the fields of Science and Engineering with the ability to apply these concepts to define problems, collect data, establish facts, deal with concrete and abstract variables and draw valid conclusions
Ability to apply advanced mathematical concepts to problem analysis and resolution utilizing correlation techniques, frequency distribution, permutations, and factor analysis
Ability to manage multiple tasks and priorities, and establish short and long-term planning horizons to complete these duties
Ability to work effectively as a team to accomplish deadlines and objectives, yet make independent decisions on various tasks
Knowledge of cGMP guidelines as well as international regulations pertaining to the production of APIs and drug products
Knowledge of and ongoing technical competence and engagement in the field of Validation

167

Transmission System Development & Validation Engineer Resume Examples & Samples

Develop transmission hardware to optimize system performance (improve durability/reliability, improve fuel economy, reduce cost)
Powertrain System Development and Testing experience
DFSS Black Belt Certification and Red-X experience

168

Sub-system Validation Engineer Overhead Systems Resume Examples & Samples

Draft ADV Plans for the OHS/HT/RWT/IL to include in SORs
Responsible to assess Detection attribute in DFMEAs
Approve 3660 forms for each component validated
Create Evaluation Reports (ERs) to capture test results provided by suppliers or testing conducted by GM
Report progress to program teams at major milestones – especially DV by IVER MRD, VTC and VDC
At least two years of engineering experience
Hands on testing ability
Must be able to meet tight deadlines
Local travel to suppliers and test houses

169

RF System Validation Engineer Resume Examples & Samples

Set up RF lab capabilities spanning from 2.4 GHz though mm-wave
Characterize and analyze end-to-end wireless communication system performance, including antenna, RFIC and baseband
Work with internal teams and external vendors to optimize radio and overall system performance
Work with internal manufacturing engineers and external vendors on production testing and qualification of the RF components and systems calibration
Development of automated test lab equipment for lab measurements
Drive Design Verification Test (DVT) testing and actively provide feedback to system team
5+ years of experience leading RF and communication system verification and testing in consumer electronics
Knowledge on characterizing end-to-end wireless system performance, RF chip bring-up
Experience with mm-wave
Experience with RF systems, EM, antenna and phase array
Experience with digital communication systems and beamforming
Knowledge of various wireless technologies, such as WiFi, Bluetooth/BLE, 802.11ad/WirelessHD, and LTE
Experience using various lab equipments, such as network analyzer, spectrum analyzer, signal generator, oscilloscope, VSA, etc
Experience in wafer probing, system/factory calibration, and working with modem/module vendors
Knowledge in scripting for test automation and familiar with PCB design and firmware development
Ability to travel both domestically and internationally (up to 15%)

170

System Validation Engineer Resume Examples & Samples

Minimum of 5.5 to 8 years of related work experience
Experience in FPGA programming and related software usage with Firmware handling knowledge is a plus
Exposure to SVF and STAPL/JAM: Adaptive FPGA Programming is a plus
Good Knowledge in logic design and analysis
Experience with UNIX shell scripting or Perl scripting
Experience in Verilog, SystemVerilog Modeling is recommended
Exposure to SoC FPGA flow concepts
Exposure to Gate Level Simulations and Firmware Verification

171

Senior Validation Engineer Resume Examples & Samples

Candidate must be a College Graduate with a Bachelor’s degree in Electrical or Computer Engineering (or equivalent)
Candidate should have 6+ years of related work experience
Experience with communication busses (GPIB, RS-232, RS-485, SPI, I2C, USB, EBI, Ethernet, etc.)
Experience with Analog peripherals (ADCs, DACs, Comparators, OpAmps, CTMU)
Experience with Clock subsystem and Reset subsystems (BOR, POR, Band-Gap, WDT, DMT, etc.)
Experience with microcontrollers, FPGAs, and embedded systems
Able to work well in a team environment
Able to make decisions and adapt real-time
Able to prioritize tasks and execute to rigorous and dynamic schedules
Good computer skills, familiar with Windows and MS office suite
Prototyping skills
Ability to understand and generate engineering drawings
Comprehensive record keeping and detailed debugging notes
Comfortable interfacing with a variety of engineering groups (Design, Verification,Production Test, and Applications)

172

Senior Validation Engineer Resume Examples & Samples

Participate in new product design meetings and drive test features required for the successful evaluation of new products
Validation solution development for new products (software/hardware/documentation)
Actively participate in the product development teams throughout the NPI cycle
Collaborate with designers, product, test and applications engineers
New product bench evaluation and characterisation
Identification of bench-top test equipment for the validation of new products
Creation of validation and characterisation reports
Drive validation and characterisation review meetings
Generation of test equipment automation software such as labview or lab-windows
BS/MS in EE/ECE or HNC / HND with equivalent work experience
Able to work under pressure in a highly paced, dynamic R&D environment
Positive and friendly attitude
Excellent team-player who positively interacts and shares knowledge
Capable of self-study/training/learning
Innovate and creative and Attention to detail
Focus on efficiencies of time, work effort, decision making and $ expenditures
Build a plan and work to meet or exceed that plan
Treat every $ of the company’s money respectfully
If in doubt, ask your boss

173

Validation Engineer Resume Examples & Samples

Degree in Telecommunication, Computer Science, Electronic Engineering or equivalent
Solid experience in validation with C or C++ program and well known about TCP/IP protocol
Good knowledge of GSM/EGPRS/UMTS, Internet protocols principle and related product features such as AT command, TCP/IP, SMS, Voice Call, Data, Fax, and GPS
At least 2 years of experience in software testing/debug with C or C++ is a must, prior experience in the area of TCP/IP, AT command or IPV6, IPSEC, Linux or software development for wireless product is preferred and as an asset
Be a team player who thrives on problem solving & collaborates effectively with others

174

Xeon Fpga Platform Validation Engineer Intern Resume Examples & Samples

Strong technical and problem solving skills
Strong written and verbal communications skills
Ability to define and execute tasks with limited direction
Experience working with Heterogeneous FPGA, GPGPU hardware systems

175

Validation Engineer Resume Examples & Samples

Develop procedures, methods and tools for test, verification and certification of products
Develop procedures and tools for testing, calibration and verification of test equipment, cooperating with Test Engineers and outside engineering as required
Review and interpret Customer Requirements and develop DVP&R / test plan including, but not limited to, EE, DV, PV testing
Participate in fixture/equipment design review, or as appropriate, lead the test fixture design, procurement, construction, verification, and runoff activities
Develop and maintain timing plans and open items lists for test projects in order to meet project test timing requirements
Participate / support quote activities by review of ADVP&R, DVP&R, test plans, work plans and cost estimates for test systems and testing, as appropriate
Receive and validate required testing inputs (Specifications, Prints, Test Request, Test Plan…)
Monitor testing; perform various product validation testing
Create test reports as assigned. Review, modify & approve test reports
Assist and train the Test Lab Technicians and Specialists on new test methods, test equipment, troubleshooting and repairing test samples, etc.
Determine if New Equipment Needed/Order/Train
Periodic travel to customers, suppliers and other VAST / STRATTEC facilities as required
Solid knowledge in electronics; analog, power and digital
Able to read engineering prints, specifications, and other complex technical documents
High level of interpersonal skills, demonstrated ability to work independently and with others
Previous experience in a mechnical or electrical test laboratory
Knowledge of Quality Control principles and methodology

176

Connected Eco System Validation Engineer Resume Examples & Samples

Lead Cross-Functional E2E Infotainment/Telematics Feature Validation
Work as a key GPD validation contact for interactions with GCCX/Back-Office and GM Validation with regards to Infotainment and Telematics; Interface with GCCX/Back-Office to include the backend enablers into telematics/infotainment validation
Work closely with and be knowledgeable about GCCX/Back-Office & the vehicle engineering teams’ efforts to address questions about new E2E connected feature development and implementation timelines
Plan, define and drive global, E2E in-region Infotainment validation execution to ensure flawless launch of new connected features/functions
Track upcoming Back-Office release, IT change requests and new feature content rollout to assess vehicle validation impacts
Review Back-Office requirements (i.e. Stories/Narratives) and work with appropriate LSVEs/SVEs/STEs to ensure that vehicle validation impacts are understood and incorporated in to CGs
Work with LSVEs/SVEs/STEs to ensure that validation execution is on track and help clear any roadblocks from back office perspective
Provide consultation and technical direction to personnel in global regions outside North America who work in the domains of Connected Infotainment/Telematics Services
Support Validation bench setup and planning activities as required
Mentor and coach GPD validation team in all aspects of connected Infotainment/Telematics domain validation
Escalate and lead mission critical connected issues globally to bring them to a solution
3+ years of successful connected telematics/infotainment experience, including direct knowledge and "hands on" involvement in the launch and delivery of Global infotainment products and working knowledge of industry standard Infotainment and Telematics systems
Knowledge of practices and methods used to validate End-to-End connected systems
Working knowledge of major automotive subsystems and Back-Office protocols
Strong appetite for technical leadership in a very diverse, fast-paced product environment with significant visibility
Understanding of roles and responsibilities of interfacing counterparts primarily in Validation, GCCX, and Back-Office
Ability to identify and remove roadblocks and lead cross-functional teams and achieve substantial results without administrative authority
Self- Motivated and able to work effectively independently with minimal supervision
Excellent organizational and people skills across all levels of employment; Comfortable and professional engagement with senior leadership levels
This position requires the legal ability to operate a motor vehicle on a regular basis

177

Senior Validation Engineer Resume Examples & Samples

Recognize, exemplify and adhere to ICON's values which centers on our commitment to People, Clients and Performance
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Travel (approximately 5%) domestic and/or international
Oversees the development and implementation of IT Validation plans
Develops, approves, executes, and reviews test scripts for completeness, accuracy and adherence to policies and procedures
Detects and reports testing errors
Evaluates Defects/Change Requests and perform testing that is required
Develops or oversees development of traceability matrices and validation summary reports
Acts as main contact person for IT groups during the implementation of a new system
Training of users on new systems
Author SOP's - how to use systems
Overall document management for all validation deliverables including, but not limited to: managing all aspects of validation package contents; assisting in the routing/approval process of documents; archiving documents
Participates In external client audits for IT Validation functions
Formulates responses to external client observations and inquires
Conducts/participates In external vendor audits and assessments
Can act as the IT Validation representative at meetings with other departments
Recommends new processes to increase the performance of the department and increase quality of its functions
Mentors and trains new members of the department on the validation process and error reporting
Manage validation schedule and testing
Coordinate team of testers
Performs additional responsibilities as requested by Management
To perform this job successfully, an individual must be able to perform. each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Knowledge of Regulatory guidelines, 21 CFR Part 11, PACS, FlexSite, ICOLabs, SOP's, all ICOLIMS related systems, and Software Development Life Cycle processes
Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills
Excellent communication including written, verbal, and listening skills
Self-motivated, detail oriented, takes Initiative and ability to work independently without close supervision
Minimum BA I BS In information systems, engineering, or science or local equivalent
Active membership In industry organizations (i.e. American Society for Quality, Regulatory Affairs Professional Society, AAMI, ISO)
Desired-
Certification in a regulatory field or certification and/or external trainings historically
Experience/Training in IT project Management

178

Validation Engineer Medical Device Resume Examples & Samples

Ensures engineering compliance to design controls and quality requirements (medical device – diagnostics)
Applies Six Sigma/Process
Works closely with R&D, Operations, Quality, Regulatory and Compliance, suppliers and other groups
Provides technical input as appropriate
Ensures effective implementation of risk management requirements to prevent unanticipated failure modes and quality issues
Provides input as needed to regulatory inspections
Executes failure Investigations and corrections of design related quality issues
Utilizes advanced Quality Engineering tools (data analysis, statistics, sampling plans, etc.) to ensure effective product development
Participates in post-product launch failure investigations

179

CPU Validation Engineer Resume Examples & Samples

Development of hardware emulators
CPU verification test bench, test plans
Coverage monitors/assertions and infrastructure

180

Customer Engagement Validation Engineer Resume Examples & Samples

Working knowledge of HW and SW development life cycle from concept to product
Good experience in SW development in C/C++
Experience in Logic Design, VHDL, Verilog RTL, verification- Scripting in Perl, Python, TCL, or some other scripting language
Experience in validation or enabling silicon DFD capabilities with expertise in areas of pre-silicon and post-silicon verification/validation processes and challenges
Expertise in CPU/Microprocessor architecture
Direct experience in silicon bring-up, debug, and validation of design for debug features
Software Skills: Python, Perl, Assembly Language, JAVA
Familiarity with debugging tools like source code debuggers, GDB etc
Experience with industry standard ATE test platforms
Working knowledge of DFT techniques for high performance processors and large complex SOCs

181

Intern, Validation Engineer Resume Examples & Samples

Writes and executes process validation/verification protocols (IQ OQ PQ) for development/manufacturing test, equipment, systems and processes including re-assessment/re-validation activities
Writes and executes software validation plans, requirements, protocols, SOPs and reports
Provide guidance/preparation of process documents (Operating Procedures and/or Work Instructions and forms/templates)
Interface with the appropriate Technical and QA personnel to obtain and understand current and new process activities
Upper division bachelor’s student in Engineering or Life Sciences required
Must be team oriented and have excellent interpersonal skills
Must have excellent written and verbal communication skills with ability to clearly articulate requirements and approach to business process owners

182

Validation Engineer Resume Examples & Samples

Planning and execution of cleaning validation program, including process monitoring, compliant with FDA and ISO requirements
Develop user requirement specifications and operational SOPs for cleaning of process equipment
Act as process engineering lead for developing cleaning development strategy
Perform risk assessment and gap analysis for site cleaning programs with laboratory washers and portable CIP systems
Risk rank cleaning remediations and generate action plan to correct priority items
Create cleaning cycle development strategies for a variety of equipment including: fixed tanks, portable tanks, valves, pumps and labware
Perform spray coverage testing, cleaning verification/validation swabbing, and review of QC results
Perform piping design and flow calculations for CIP systems
Perform batch record review, including verifying calibration and in-process data
Perform commissioning and provide automation support for CIP systems, including PLC systems
BS degree or higher in chemical engineering or a related engineering or scientific discipline
A minimum of 5 to 10 years industry (Biotechnology, Medical Device, or Pharmaceutical) experience
Familiarity with cleaning of process equipment, including CIP cycle development and optimization, piping design, and fluid dynamics
Familiarity with sanitization or sterilization of process equipment
Familiarity with plant control software, including PLC
Familiarity with engineering project management
Proven experience with: CIP cycle development, cleaning validation, protocol development, execution, troubleshooting, and summary reports
Industry experience related to cGMP manufacturing, validation, programming, or chemical process design
Strong computer knowledge including Microsoft Office products
This position does not offer Relocation Assistance
Bachelor’s degree with minimum of 5 years of post-degree experience
IND-SDG

183

Validation Engineer Resume Examples & Samples

Equipment Qualification
Utilities Qualification
Process Validation
Cleaning Validation
Temperature Mapping Studies

184

Chassis Structures & Suspensions Subsystem Validation Engineer Resume Examples & Samples

BS in Engineering with 2 years related work experience, or equivalent work experience required
This position requires the ability to legally operate a vehicle on a regular basis
Driveline Design or Release experience
Automotive supplier experience, Contract Engineer experience, Test Engineer Experience
Experience working with automotive suppliers or external organizations

185

Windows Drivers Validation Engineer Resume Examples & Samples

3+ years of programming experience in C
3+ years of experience developing automated tests for Windows environment
3+ years of experience troubleshooting/diagnosing issues with Windows OS/applications
Knowledge of validation automation aspects
Working knowledge with validation automation frameworks like Multitester
Thorough knowledge of Windows internals
Prior experience working on storage related validation and architectures

186

ECU Validation Engineer Resume Examples & Samples

Develop validation test plan from requirements
Perform bench and HIL testing against plan
Capture and report issues into tracking system for resolution
Prepare test report documentation
Final responsibility for ECU quality
Bachelor's Degree in EE, CE, or CS
3 plus years experience electromechanical or electronic systems required
Excellent time-management skills
C / C++
CANalyzer/CANape/CANoe
Vehicle SPY
Bosch CAN 2.0 and/or generic ISO specs for CAN communications
CMMI
ASpice

187

System Validation Engineer Resume Examples & Samples

Prepare test vehicle and equipments to meet testing requirements, including electrical and mechanical vehicle modification
Conduct vehicle testing on test courses and public roads, including overseas location. Activities involve function check of test system and field data collection
Analyze test result, generate test reports and help communicate with development team, providing details of issues encountered in the field
Keep track of test progress of team globally for reporting to project team

188

Validation Engineer Resume Examples & Samples

Is tactile, plans and implements validation testing and/or development testing for programs
Maintains validation test plan status for new and current programs
Helps conduct design reviews based on failure modes on durability vehicles & supplier tests
Provides technical validation leadership for advanced technology development
Travels as required
Specific knowledge of engineering failure mechanisms and how they relate to customer failure modes
Familiarity with production processes such as plastic injection, paint systems, chrome plating, and vacuum metallization
This position requires the legally ability to operate a motor vehicle on a regular basis

189

Validation Engineer Resume Examples & Samples

Select and utilize a wide range of appropriate statistical methodologies and techniques
Participate on technical project teams as subject matter expert on validation regulations/procedures
Give advice to project teams, develop/review and approve validation protocols and final reports
Assist with/conduct validation studies
Design process characterization studies, conduct statistical analysis of results using Minitab or equivalent to identify critical parameters and improve process capability
Participate in project planning, scheduling, and tracking
Develop and implement procedures to comply with corporate and industry standards
Mentor support, validation and staff engineers

190

Validation Engineer Resume Examples & Samples

Track & plan future OTA validation based on present and future ECU availability
Develop and implement new test methods to improve quality/efficiency. (automation, etc)
Bachelor of Science degree in Electrical Engineering
Minimum of 5 or more years of validation experience

191

Senior Validation Engineer Resume Examples & Samples

ADV&R Process for Supplier Parts
PQMS
Deep knowledge of CR/DN & GVDP process tools
Fidelity Process
MVSS/Regulatory Self - Certification
Experience on PRTS resolution and system knowledge
Knowledge of WOs process & E2
VDS RPOs
Test Hardware planning and ordering
DRBTR
Statistical tools
DFSS black belt
Costumer focus
Building effective teams
Managing vision & purpose
High Understanding of engineering theory and principles of operation of mechanical/electrical mechanisms
Interpersonal skills to work effectively with others
Demonstrated proficiency in technical and professional skills in job-related area required
Coaching to Engineering community about validation procedures and requirements
80% of English (listening, speaking & writing)

192

Validation Engineer MI Resume Examples & Samples

Develop procedures and tools for testing, calibration and verification of test equipment, cooperating with Test Engineers and Outside Engineering as required
Review and interpret Customer Requirements and develop DVP&R / test plan including, but not limited to, EE and DV testing
Meet with customer, as required, to develop and get approval of test plans
Participate in Fixture/Equipment Design Review, or as appropriate, lead the test fixture design, procurement, construction, verification, and runoff activities
Develop and maintain Timing Plans and open items lists for Test System projects in order to meet project timing requirements
Participate / support quote activities by coordinating / developing DVP&R, work plans and cost estimates for Test Systems and Testing, as appropriate
Ensure test equipment is properly calibrated and certified according to the corresponding procedures
Monitor Testing; Perform various product validation testing
Create test reports
Review, Modify & Approve Test Reports
Ensure accurate document, record and archive measurement data pertaining to product parameters and testing
Assist and train the Test Lab Technicians and Specialists, when required, in troubleshooting and repairing returned products from the customers
Identify Outsource Test Locations for Unusual Testing
Quote Outsource Testing
Order Test Supplies (Cables, Latches…)
Participate in the Problem Resolution Process as required by STRATTEC Quality Processes
Participate in Root Cause Analysis of testing failures
Participate in Customer and Team Meetings
Participate in product design reviews
Experience in testing electronic boards, modules and test equipment
Experience in developing test instructions and procedures
Excellent analytical reasoning and problem solving skills with ability to apply it to unusual or difficult problems
Must be very well organized, able to work well with a diverse cross-functional team and varying personalities/cultures
Able to be a self-starter and willing to perform a wide range of engineering duties
Previous experience in a test laboratory
Previous product engineering experience
3D modeling experience (as required, for fixture design and construction)
Previous project leadership experience
Experience with customers

193

Validation Engineer DK Resume Examples & Samples

Think beyond the datasheet and around design corners to find elusive bugs. Able to think of test cases and customer usage model that may violate the assumptions of designers and systems engineers
Develop automated test framework, regression test suites in LabVIEW and TestStand to optimize validation efficiency
Analyze test results and identify failures/defects using business intelligence tools such as Spotfire
Synthesize RTL designs targeted to custom Xilinx FPGA platforms, test and debug the FPGA model and perform full-chip emulation on FPGA platform
Design FPGA emulation and silicon validation board schematics and bring-up the platforms
Develop and work with supporting HW (FPGA, DSP, ARM, 8051, JTAG, debuggers) and SW (C, Assembly, scripts) collaterals
BS in Electrical or Computer Engineering with 5 years of experience in related field OR MS in Electrical or Computer Engineering with 3 years of experience
Minimum of 3 years of experience in specialized areas such as FPGA-based emulation, synthesis, Verilog, pre and/or post silicon validation, mixed-signal IP block design/validation, audio related signal processing and algorithm, validation related automation framework
Hands-on experience in lab equipment such as oscilloscopes, signal generators, audio analyzers, logic analyzers, spectrum analyzers for measurement and debugging issues
Sound electrical engineering knowledge in analog, digital, power electronics or audio engineering. This includes mixed signal building blocks such as ADC, DAC, PLLs, amplifiers, signal processing and measurement, IC control/communication protocols
Self-motivated with excellent problem solving skills and attention to detail are highly valued as you will need to understand silicon, board and software interactions
Demonstrated aptitude in system understanding of various industry interface standards such as I2C, SPI, USB, I2S, TDM or high-speed control/data bus as examples
Expertise in Validation automation and scripting/programming languages such as MATLAB, LabVIEW, C, Python or similar

194

Validation Engineer Resume Examples & Samples

Lead process validation activities involving Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ)
Conduct process validation studies and/or Design of Experiments to challenge manufacturing processes
Use and implementation of Statistical Process Control techniques (SPC) and Six Sigma
Determine correlation between product defects and process variables
Lead and/or assist FMEA activities
Provide leadership in troubleshooting process failures and implement controls
Review, revise, and approve manufacturing procedures in areas of responsibility
Lead projects and develop capital requests for processes that require improvement
Lead and/or assist CAPA activities
Use DMAIC and Lean Manufacturing techniques to review processes for improvement opportunities
Develop tools to monitor process, maintain control, and taking corrective action when necessary
Assist in the improvement of process yield, process deviations, and customer complaints
Bachelors Degree in Engineering or related scientific field (Course in Statistics required)
Strong working knowledge of GMP and ISO requirements for medical devices, statistical quality tools, SPC, Process Validation, and FMEA. Ability to interface with regulatory bodies to present technical information
Understands applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE
Six Sigma and Lean Manufacturing experience highly desired
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) highly desired
Strong skills in root cause analysis and problem solving
Minimum 2 years experience with project management
Ability to handle multiple assignments
Ability and desire to lead process improvement initiatives
Excellent organizational, troubleshooting, and problem solving skills required
Excellent written, verbal communication and presentation skills. Understands how to present information dependent upon the level of the audience

195

Infotainment Connected Lifecycle Validation Engineer Resume Examples & Samples

Develops validation designs and methods to ensure integrity of feature delivery across the entire connected “ecosystem”
Participates in root cause analysis with stakeholders within connected “ecosystem”, providing production support to identify system and implementation issues
Executes testing across features both in-vehicle and bench testing
Designs and balances system test procedures
Meets deadlines for production intent product timing
Communicates, coordinates, and consults with other engineering departments, business organizations, and suppliers
Support connected lifecycle test activities, tracks issues, and works on immediately resolving internal roadblocks to ensure test continuity
Interacts with Global Execution Leads, Process Lead, Back Office teams, Infotainment Program Managers, Design Release Engineers, and System Test Engineers to effectively communicate all issues
Collect test results and prepare status reports for higher management
Knowledge and understanding of Infotainment or Telematics functionality and requirements
A well-developed understanding of in-vehicle networking protocols such as CAN and associated tools and techniques
Three to Five years of professional engineering experience

196

Brake Subsystem Validation Engineer Resume Examples & Samples

5 years related work experience, or equivalent work experience required
Test or validation experience
Design or release experience
Automotive chassis experience - design, development, test and/or validation

197

HW Validation Engineer Resume Examples & Samples

Developing or using checking software to compare model behavior against a specification
Analyzing micro-architectural features to identify possible problem areas
Previous experience in pre-silicon or post-silicon validation/verification preferred
Strong background in computer architecture
Outstanding communication and team work skills
Understanding of object oriented programming, data structures, algorithms and digital logic

198

System Validation Engineer Resume Examples & Samples

Bachelor degree and above of computer science or electronic and electric engineering
Minimum three years' experience of hardware development and system verification in consumer/electrical products
Familiar with system board design/debugging and usage of lab equipment like Oscilloscope and Logic analyzer
Experience of silicon verification, test program development and test plan execution
Understand PCI/USB/PCI-E/ETHERNET/SPI/SATA bus protocol
Knowledge of RTL language, in-circuit emulation and FPGA fast prototyping is an advantage
Experience of C/C++ Programming language, Knowledge of XDSL, DSP, ETHERNET switch, and wireless LAN is preferred
Team player, very proactive and self-motivated

199

Validation Engineer Resume Examples & Samples

Writes and executes commissioning, validation, and qualification protocols for process equipment, as well as, computerized or automated systems
Generates final reports
Resolves protocol discrepancies and deviations
Reviews vendor generated validation protocol packages
Generates deviations, CAPAs, root cause analysis, and assists with deviation investigations
Participates in the reviews and approvals of internal and external SOPs as they relate to validation
Supports change control assessments and deliverables
Develops or revises validation SOPs
Develops or revises validation master plans and reports
Responsible for the generation of complex protocols using a risk based approach that meets current regulatory requirements and industry practices
Manages or oversees validation projects which may involve: defining validation scope, risk assessments, strategy, validation plan, and validation schedule
Bachelor’s Degree in engineering, science or a related field preferred
Minimum of 9 years of operational validation experience in a cGMP manufacturing environment (or Master’s Degree and 7 years of experience)
Experience with aseptic fill finish automated process equipment preferred
Familiar with data logging systems (such as Kaye/GE Validator, ELAB, or Lives International)
Basic knowledge of calibration activities, preventative maintenance, and cGMP quality systems preferred
Practical knowledge of cGMP regulations required
Ability to effectively manage time and prioritize tasks independently
Ability to manage both day-to-day operations, as well as, project work in a fast-paced environment
Ability to effectively manage several tasks simultaneously
Must be self-motivated, able to work independently, and have a proven ability to work in a team environment

200

Validation Engineer Resume Examples & Samples

Assists in scheduling/planning/executing engine test programs
Coordinates build of test fixtures from existing designs and drawings
Coordinates set up and operation of test devices and measurement tools
Procures parts/engines/other items for test setup
Gathers and analyzes data and writes technical reports
Creates and delivers presentations of plans and results
Develops and writes test procedures related to engine testing
Establishes in concert with manager a course of action to accomplish completion of the job and/or project
Bachelor of Science in Engineering - Mechanical/Electrical/Chemical
Basic understanding of internal combustion engines
Demonstrate proficiency in oral and written communications
Ability to travel as required for offsite testing (typically not extensive)
Exposure to/experience in testing engines/engine components or other complex mechanical devices
Proficient with computer and data acquisition systems
Knowledge of computer software as it pertains to engineering data collection and processing

201

R&D Validation Engineer Emergency Lighting Units Resume Examples & Samples

Design and define the optimal testing specifications as per the requirements defined by the architects of the emergency products platform
Define and configure the testing and validation environment, including the development of scripts
Manage and ensure the creation of validation plans for the various sections, in collaboration with the team members
Develop and execute automated tests, covering both functionalities and diagnostic needs
Ensure an understanding of the customers’ needs as well as the various codes and standards which can impact the designs
Participate in project planning and follow-ups with other involved members
Participate actively in design review meetings
Ensure that the designed products meet the customers’ needs, as well as the quality and safety standards
Provide required technical support and training to engineers participating in projects, as well as to regional engineering teams
Knowledge in BMS protocol (Bacnet, KNX, Modbus)
Knowledge in lighting products, like LED and previous technologies
Functional English required, spoken and written, as well as a second language, an asset
Autonomy and leadership for managing priorities in line with targeted goals
Occasional travelling possible

202

Validation Engineer Resume Examples & Samples

Responsible for the engineering development project DVP&R, to ensure design is adequately verified to customer and AAM requirements
Plan and prioritize the testing with the system, component and test engineers
Develop the plan for writing Test Orders and any post-test, detailed photos, Materials Lab requests to document the sample’s material & its failure mode, or required NVH qualification
Ensures project DVP&R is completed and approved in accordance with the engineering project milestones and AAM procedures
Perform Duty Cycle Analysis (DCLA) to AAM documented procedures, with consistent reporting of conclusion linking a DCLA to a particular Test Order, Road Load Data, and customer or AAM internal requirement
Ensure consistency in tests and methods across the platform of products, and assist with determining the standard tests that will be used to verify components as revisions occur during the engineering project
Ensure adequate documentation of prototypes that will be used for verification including where verification may include limit samples and the dimensional or metallurgical state of the test samples for internal or customer reports
Co-ordinate and track supplier component testing such as seals, gaskets, bushings, bearings, lube, clutch plates, etc. as well as fastener testing which may be performed internally or by a supplier
Author customer level test reports documenting test conditions, part level, & failure mode. Tie the test to the customer requirement and present conclusions regarding the acceptability of the test results
Support customer validation including responding to test incidents or PRTS issues. Investigate part usage and test conditions of incidents and participation in the post test tear-down, root cause determination, corrective actions, and writing PRTS responses

203

Validation Engineer Resume Examples & Samples

Support the Engineering group in the qualification of process equipment
Provide input to the design and specification of new or modified equipment
Produce material certifications via XRF
Wrote SOP’s
Initiate calibrations
Write Preventative Maintenance procedures
Write IQ, OQ summaries
Enter certifications, Calibrations, SOP’s, PM’s, etc into a document management system
Create and maintain Equipment Master Files
Complete Engineering Change Orders for equipment modifications
Prepare FAT documents

204

Validation Engineer Resume Examples & Samples

BSEE with at least 5 years industry experience
Experience with High Bandwidth scope, TDR and VNA measurement equipment, automation and scripting
Experience with hardware and software troubleshooting
Understanding of high-speed signal interface standards such as DDR2/3, USB2/3, DP, HDMI, SATA, PCIe, etc
Work experience with Phy Layer and SerDes characterization a big plus
Solid experience in SI/PI and ability to run simulations using ADS, HSPICE, PowerSI and PowerDC
Experience with PCB schematic and layout tools such as Allegro, OrCad, etc
Previous electrical design experience in consumer electronics
Ability to apply signal integrity concepts to laboratory data for analysis and troubleshooting
Ability to manage multiple complex projects

205

RF System Validation Engineer Resume Examples & Samples

Minimum three years of experience in RF testing / validation, debugging of the wireless systems and test development
Knowledge of cellular technologies: 2G, WCDMA, TD-SCDMA, LTE
Hands-on experience with RF test equipment
Familiarity with 3GPP specifications
Ability to understand complex technical systems and contribute in solving complex technical issues
Experience in programming in Python or similar scripting language preferred
Experience with instrument control by means of NI-488.2 an advantage
Test plan definition, planning and execution
Participation in the internal project meetings and costumer communication
Ability to work independently and in the team

206

HW Validation Engineer Resume Examples & Samples

Primary Product HW platform Validation lead from Planning to LVM
Monitoring, Tracking day to day EVT progress
Ensure that HW meets the design specifications
Working understanding of oscilloscopes and best-practice probing concerns/techniques, power supplies, electronic loads,
Power-loss/Drive backup circuit understanding and testing
Perform system level testing across VT corners. Host power cycling/loss testing and stressed overnight functional testing etc
Capable of working effectively in a cross functional team environment with FAE, Hardware, Software, and ASIC engineering teams on validation testing
Strong time management skills with the ability to prioritize and manage multiple tasks simultaneously
Must be detail-oriented with strong analytical skills
Work effectively and efficiently with minimal supervision
Mentor and train junior engineers and engineers in other disciplines
Exceptional problem solving skills to recommend validation strategies and find solutions
BSEE and 12+ years of experience; or an MSEE and 9+ years of experience

207

RF Systems Validation Engineer TX Resume Examples & Samples

Bring-up, verification, and optimization of RF modules and subsystems for cellular applications with strong focus on the transmit path
Programming of necessary test-cases and test-vectors as well as reviewing the test plans
Test-verdicts according to the system-requirements including test-case database updates
Debugging and system optimization by HW (e.g. matching) as well as SW (e.g. programming based parametric tuning)
Transmit power control optimization
Design team support (TX specific systems, Envelope Tracking, ...)
Job-related travel activities may occur
RF experience in general with strong focus on Transmit
Cellular RF (2G/3G/4G)
Hands-on experience with RF-Test equipment
Test case planning and tracking
RF HW System Integration / validation with FW
Experience with Transmit power control
Knowledge in 3GPP cellular standards
Co-existence with other wireless systems
Preferred Degree: Engineer (B.Sc. or M.Sc.)
Preferred Major: Electronic Engineering, Radio Frequency
>3 years of relevant job experience is preferred but not mandatory. The right attitude is more important for us than experience
Cellular RF (2G/3G/4G): Experienced
RF-Test equipment / Automation: Experienced
Transmit power control: Experience preferred but not mandatory
English language: Fluent
German/Danish: Optional

208

Validation Engineer Resume Examples & Samples

Generating, executing, and reviewing protocols for Utilities, Manufacturing and Computer Systems
Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Prepare, maintain, or review validation and compliance documentation, such as engineering change controls, schematics, or protocols
Summarize Protocol execution and results for the IQ/OQ/PQ Summary Report
Coordinate Validation Projects and ensure project timelines
Generation of Process, Equipment and Computer Systems Periodic Reviews
Prepare Equipment Qualification, Utilities System Qualification and Continuous Process Validation (CPV) memos associated to Annual Product Reviews
Able to provide direction to team and external department related functions and activities
Able to multitask and respond to shifting priorities
Proficient with computer software (MS Office) and have expertise with spreadsheets
Good communication skills, both written and verbal (English and Spanish)
BS/BA degree from an accredited college or university in an Engineering or Science discipline
Minimum 2 years of validation experience in a regulated industry or equivalent validation experience, including ten years of food or pharmaceutical manufacturing or cGMP experience
Knowledge of pharmaceutical solid dosage manufacturing equipment, critical utilities, and computer systems, a must
Prior mechanical and process equipment experience

209

Active Safey Feaure Validation Engineer Resume Examples & Samples

Must have a US Driver's License
High level of oral and written communication skills. High level of organizational skills - Able to manager multiple projects across multiple programs
Ability to act as a single voice for feature level testing for assigned features
Knowledge of GMLAN, CAN based communication

210

SOC Validation Engineer for Server Processor Resume Examples & Samples

Problem-solving Skills
Ability to Multitask
Strong Written and Verbal Communication Skills
Ability to Work in a Dynamic Team-Oriented Environment Qualifications
System Verilog VVM/OVM/UVM and/or Object-Oriented Programming Techniques
Verilog and/or similar HDLs
Computer Architecture and Digital Logic
Linux/UNIX and related Tools
Design/Verification Tools such as VCS, Debussy, Verdi, DVE, DVT, & GDB
Test bench, Architecture Knowledge on server RAS flows and how to validate RAS flow at SOC will be added advantage

211

Validation Engineer Resume Examples & Samples

Analyzing product and sub-system requirements
Analyzing and verifying medical device designs
Writing detailed test procedures that evaluate medical devices and systems against documented software requirements. Includes black box, exploratory, and white box testing
Executing test procedures on a web or client/Server platform
Maintaining and controlling test execution records using good documentation practices
Technical writing, including development of test reports
Works with system level, multi-disciplined engineering projects
Requires limited direction
Makes risk-based decisions, balancing business and compliance issues
Communicates at all levels of the organization
2+ years with BS or MS, 4+ years with Associates
Disciplined, regulated industries, medical device experience preferred, including FDA’s 21 CFR 820/ISO 13485 experience
Software development using ISO 62304 or equivalent
Risk Management using IEC 14971 and IEC 60601 or equivalent
Familiarity with QTP and/or UFT

212

Embedded System Validation Engineer Resume Examples & Samples

Bachelor's degree in Electrical, Electronics, Computer Engineering or equivalent with experience in embedded system verification/validation
Experienced in using advanced system design and validation methodologies and technologies such as FPGA prototyping, emulation, simulation and co-emulation
Experienced in flash validation in embedded system is a strong plus
Familiarity or experience in OS driver development in embedded Linux or bare-metal library development is an added advantage
Familiarity or experience in Altera's Quartus design software or Altera's SoCEDS is a strong plus
Knowledge of any IP or I/O interface such as PCIe, Ethernet, USB, QSPI, eMMC, NAND, UART is an added advantage
Experienced with scripting language such as Python/Perl/TCL/shell scripts and OS such as Windows/Linux
Exceptional analytical, problem solving and communication skills, initiative, promote innovation and teamwork
Self-motivated and ability to excel in a team environment
Demonstrates fundamental values such as accountability, integrity, a winning mindset and highly motivated to learn or adapt to fast changing environments

213

Validation Engineer Resume Examples & Samples

Manage the Validation Process activities during the product design cycle from product concept to production launch
Manage critical path timing issues to ensure on time test completion
Responsible for requirements analysis and test plan generation. Develop validation test procedures using success based test methods, extended life test methods, test to failure test methods, and overstress test methods
Analysis of test data and comparison to requirements
Develop test hardware and software necessary to validate Active Safety Electronics products. This includes, but is not limited to, procurring capital assets, developing test methods and fixtures, writing test software, designing analog and digital load board designs, designing cables, and applying engineering principles as required
Analyze data. Create test summaries and reports
Support Start Center actvities
Participte in product development team activities and customer interface
Candidates must demonstrate strong professional and technical competence. They shall possess excellent oral and writen communication skills, be responsible and capable of self direction, have strong leadership skills driving self and organization to improve performance, be a team player, and display a high level of maturity. They should willingly accept challenges, be customer focused, possess excellent technical knowledge and skills, and be highly motivated
Programming experience in C/C++, LabView, and LabWindows. Microprocessor knowledge
A strong working knowledge of computers, MS Office applications, and a drawing package such as Visio, Circad or etc. is required. Also necessary is a familiarity with test equipment: i.e. DMM, ARB, Power Supply, oscilloscopes, generators, and etc
General understanding of pneumatic switching systems and other types of pneumatic controls

214

System Validation Engineer Resume Examples & Samples

Planning, developing and executing validation tasks
Investigating and adapting appropriate existing validation tools
Planning, developing and executing code and tools to keep metrics automatically updated
Planning, developing and executing Systems Engineering Best Practices
Designing, developing and debugging Validation Tools and SW
Participating in Product planning and release meetings and decisions
Engaging with various internal cross-team validation organizations

215

Thermal Validation Engineer Resume Examples & Samples

Plan, implement, execute, and document thermal characterization instrumentation for enterprise/client Solid-State Storage Devices SSD, so as to verify various component thermal profiles over operational scenarios, and SSD modes of operational
Set up Data logger equipment configuration, to collect thermal data
Over the prescribed workload scenarios, and compiles reports to determine viability of product thermal solution under evaluation

216

PSG Timing Validation Engineer Resume Examples & Samples

BS/MS in Electrical/Electronic Engineering or equivalent, with >8 years of industry experience in semiconductors design or manufacturing
Strong statistical analysis and digital logic knowledge
Exposure to multiple ATE tester platforms and proficiency in automation scripting are advantages

217

Validation Engineer Resume Examples & Samples

Document the results of the test, including issue reporting into proper tracking tools. Maintain and update issues as they are resolved
Assist in root cause analysis and validation of resolution for problems identified during testing, providing additional information and data as required to the design teams
Interface effectively with support groups and internal customers such as engineering, marketing, platform, etc
Submit timely and concise reports covering system performance, reliability, durability, customer appeal and safety. Maintain accurate and comprehensive test records for reference and analysis
Aid design team in the tuning exercises for machine Auto Guidance features for the PS&T software on agricultural machines
Minimum Bachelor's Degree in Agricultural, Mechanical, Electrical Engineering, or computer science
Minimum 1-3 year experience with Auto Guidance Systems
3-5 years experience in electronic troubleshooting and diagnostics or a related field
Communications protocol experience and understanding required (e.g. Serial, CAN, Cellular, Wifi, GPS, ISOBUS)
Ability to demonstrate good written and verbal communication skills required
Ability to demonstrate good computer skills with Word, Excel, MSOffice suite
Agricultural, construction, automotive or similar background preferred
Closed loop control system appreciation and understanding -- electro-hydraulic, electrical and electronic systems
Customer driven focus
Use of Vector tools
Experience with Precision Farming and/or Telematics systems

218

Validation Engineer Resume Examples & Samples

BS/BA in a Scientific, Engineering or computer related discipline
Minimum of 1 years of industry- related experience (Validation, QA, QC, manufacturing)
One year of experience in validation or engineering in a biopharmaceutical manufacturing environment
Authors final reports summarizing execution validation/qualification protocols and support documents (amendments, repeat test forms, addenda and deviations)
Interface with Validation, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution
Assist in scheduling and coordination of validation activities with system owners and key stakeholders
Responsible for periodic revalidation/requalification of major process equipment
Participate in change control reviews
Responsible for continuous improvement of validation programs
Participates in site projects and initiatives as necessary
As necessary, will be assigned to carry out laboratory based biopharmaceutical process development/investigational activities

219

Validation Engineer Resume Examples & Samples

Perform tests and validation test sequences under the scope of the Environmental Test Laboratory (ENV Lab) as directed by validation engineer and/or lab manager
Uphold safety, quality and housekeeping standards in the lab. Assist senior lab staff in the development, documentation and communication of policies and standards
Maintain schedules and timelines, identify possible problem. Assess causes of problems and participate in their resolution
Maintain lab equipment, testers and fixtures. Support equipment sourcing and repairs
Post-secondary education or College/Technical Program degree in Electrical or Mechanical Engineering discipline
Proficient in MS Office programs
Experience in a test laboratory is a definite asset
Understanding of product reliability and environmental qualification concepts is an asset
Working experience with MS Project is an asset

220

Validation Engineer Resume Examples & Samples

Responsible for generating and executing validation protocols for equipment, instruments, utilities, computer systems, control systems through commissioning, URS, IQ, OQ, and PQ phases
Responsible for temperature mapping of facility Controlled Temperature Units, Stability Chambers, Warehouse Space, Autoclave, Incubators, Humidity Controlled Rooms/Glove boxes and Cold Rooms. Involves the startup of new Controlled Temperature Units
Generate and execute cleaning validation studies, execute sprayball coverage testing, generate equipment characterization reports, and equipment sampling SOPs
Resolve CAPA’s and change controls related to validation protocols

221

Senior Validation Engineer Resume Examples & Samples

Work closely with Validation Change Owners to plan and draft validation documents compliant with Plant and Corporate policies and procedures; ensure proper execution/documentation of test results, and compilation of validation packages. Responsible for reviewing, executing and approving validation documents
Present or work closely with the Validation Change Owners to present proposed validations to the Plant Validation Review Board and completed validations to regulatory and third party representatives during inspections and audits
Ensure validation packages contain all relevant information, rationales, references, and data to support the change and that all reports and protocols are reviewed and approved as appropriate
Perform data analysis of site processes
Assist the Validation Change Owners with the process of obtaining validation package approvals
Develop and maintain an annual plan of cleaning validations and continued process verifications / process validations to be completed during each calendar year, and periodically report on progress
Supervise validation engineers and technician(s) and validation consultants to provide project and technical direction, as needed
Provides technical training in validation to plant personnel
Write or assist with the writing of Standard Operating Procedures and Validation Master Plans
Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies
Bachelor’s Degree in Engineering: Mechanical, Chemical, Electrical, or Biomedical or related science
Must have a minimum of five (5) years’ experience in a pharmaceutical GMP environment. Must have a minimum of two (2) years direct validation experience. Candidates with other technical Bachelor’s degrees will be considered if they have four (4) or more years of direct validation experience
A minimum of two (2) years of supervisory experience is required
Must have thorough knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines. Expertise in one of the following disciplines is required: manufacturing, facilities/utilities, laboratory, solution processes, sterilization, and/or controls systems/software. Must have experience talking/interacting with regulatory and third party representatives
Must have good organizational, presentation, meeting facilitation and technical writing skills. Working knowledge of statistics is preferred
Requires a high level of resourcefulness, an ability to get things done by removing obstacles, identifying and resolving problems, making difficult decisions with less than complete information provided, and finding ways to accomplish goals through innovative planning
Must maintain a thorough working knowledge of the Hospira Specification Systems. A high level of attention to details and the ability to proofread and audit validation documents is required
Must be able to work weekends and holidays as required to meet deadlines

222

Senior Validation Engineer Resume Examples & Samples

Ensure validation packages contain all relevant information, rationales, references, and data to support the change, and all reports and protocols are reviewed and approved as appropriate
Serve in the role of Validation Manger or Section Manager in their absence
Bachelor’s Degree required; Engineering: Mechanical, Chemical, Electrical, or Biomedical or related science preferred
Must have a minimum of five (5) years’ experience in a pharmaceutical GMP environment
Must have a minimum of two (2) years direct validation experience
Candidates with other technical Bachelor’s degrees will be considered if they have four (4) or more years of direct validation experience
Expertise in one of the following disciplines: manufacturing, facilities/utilities, laboratory, solution processes, sterilization, and/or controls systems/software
Must have thorough knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines
Must have experience talking/interacting with regulatory and third party representatives
Must have good organizational, presentation, meeting facilitation and technical writing skills
Must demonstrate a high level of resourcefulness, an ability to get things done by removing obstacles, perceiving and resolving problems, making difficult decisions with less than complete information provided, and finding ways to accomplish goals through innovative planning
Must maintain a thorough working knowledge of the Hospira Specification Systems. A high level of attention to detail and the ability to proofread and audit validation documents is required
Must be able to manage complex projects, set/achieve timelines, direct/redirect resources, and manage assigned funding

223

Systems Integration & Validation Engineer Resume Examples & Samples

User Experience and Workflow Efficiency
System Functions and System Interactions
System Reliability, Availability and Stability
Performance, Responsiveness and Scalability
Security, Intrusion and Privacy
Regulatory Requirements
Designing, planning and executing business driven system acceptance test based upon end user use cases ensuring the system meets customer needs
Act as subject matter expert or test lead for one or more system functional or system quality focus areas and will represent the Quality Management team in this function to other internal and external project teams and stakeholders
Develop and implement technically complex manual and automated methods and procedures to ensure that the products and system are free of flaws and function as desired
Design, install and maintain sophisticated system level test setups and test beds and perform product testing and analysis to ensure that potential defects and failure rates are minimized, and quality levels are maintained in the most efficient and cost-effective manner
Identify system test automation needs to continuously improve testing effectiveness, efficiency and maturity and you will be working with cross functional teams to have the required solutions implemented
Gather, analyze, report and communicate test results and test reports. You will identify trends and areas of quality concern and ensure that corrective actions are taken in a timely manner
Collaborate with field support teams, partners and other quality teams throughout the organization to analyze and replicate field issues and to determine quality trends and recommend corrective actions
Fully understand agile testing methods and system quality models and understand how to utilize them effectively in an agile development and testing environment
7+ years of direct working experience in integration and validation of complex control systems
5+ years of direct working experience with wireless systems and protocols (WIFI, Bluetooth, ZigBee)
5+ years of direct working experience with Building Automation, Home Automation and Lighting Control Systems and their protocols (BACnet, DALI, KNX)

224

Principal Emulation & Validation Engineer Resume Examples & Samples

Synthesize complex system on chip designs and map into various hardware emulator platforms like Cadence Palladium or Mentor Veloce
Develop system level tests using tcl, itcl, python, C/C++ languages to verify networking switch chips and systems
Create reusable design blocks, libraries and verification components for emulation
Improve and define new verification / emulation methodologies
Debug and resolve Pre / Post Silicon failures
Create and maintain emulation environment for worldwide user community
Write Complex Device Driver using C/C++ to implement feature on a flexible architecture and support and promote with wide range customer adoption

225

Manufacturing Validation Engineer Resume Examples & Samples

Ensuring regulatory compliance through Validation & Verification – Plan, execution and analysis with heavy emphasis on testers, tester SW, and other metrology equipment
Drive improved product quality by implementing cost-effective solutions of identified manufacturing issues
Participate in new product introductions through equipment and software validation processes
Coordination of manufacturing releases of software and equipment initial releases and updates
B.S. Degree in Mechanical, Electrical, Industrial Engineering, Software or related technical degree, or an Associates Degree and 3 years experience in production, engineering or troubleshooting of PC/server based systems, or High School diploma with 5 years of experience in production, engineering or troubleshooting of PC/server based systems
Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements
Previous Project Experience

226

Validation Engineer Resume Examples & Samples

To test the digital chip RTL from a User perspective on an FPGA emulation platform
Validate new digital IP and architectures on an FPGA prior to silicon being produced
Create reliable and reusable evaluation tests for complex chip evaluation on an FPGA
To work with the Verification team to off-load system-based and interoperability tests from the simulation environment
To work with the post-silicon evaluation team to ensure a smooth transition between pre and post silicon phases, maximising both efficiency and coverage
To contribute to development of a comprehensive set of emulation tools
To work with the applications and software groups to develop use-case-based testing on the FPGA
To define and run functional validation tests to prove the FPGA builds prior to FPGA distribution
Degree qualified in Electronics and/or Computer Science (or similar)

227

Server ODM Validation Engineer Resume Examples & Samples

Candidate should have 15+ years of system validation experience, with a minimum of 5 years in a senior lead role
Knowledge of all areas of validation testing, including hardware, BIOS, BMC, Functionality, Compatibility and Performance
Experience with project management related to validation planning, coordination and issue tracking
Candidate requires good problem solving skills
Excellent communication and time management skills required
Experience with regulatory, environmental and compliance tests

228

Validation Engineer Resume Examples & Samples

Administer projects, as directed, according to Validation Master Plan
Execute IQ/OQ for equipment and requalification
Execute IQ/OQ/PQ for process validations
Draft/review/approval validation protocols and reports Administer site Change Management Program Coordinate validation activities with other departments
Have the ability to problem solve with little oversight, including conducting research toaid in the resolution of issues that arise. Operate wireless temperature data loggers

229

Validation Engineer Resume Examples & Samples

Managing the planning, execution and documentation of qualification studies
Completing all assigned re-validation tests in accordance with established procedures
Maintaining validation equipment in fully operational state
Ensuring a high level of compliance with GMP and GLP standards as well as following, writing and reviewing SOPs
Collaborating with other internal stakeholders
Practical experience and knowledge of validation principles and methods is desirable
A Biotechnology background is desirable
Ability to trouble shoot and problem solve
Understanding of the principles of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) standards
Good self-management of own time and workload
A tertiary qualification in science or engineering is highly desirable

230

Battery Validation Engineer Resume Examples & Samples

Develop and execute Rechargeable Energy Storage Systems (RESS) ADV Plan
Expert knowledge of RESS content, technical requirements (SSTS, CTS, etc.) validation needs, program timing, and standard validation tests
Provide necessary documentation to lab to run testing
Verify appropriate hardware/software/cal is used for testing; update as appropriate
Monitor tests for results and completion in a timely manner
Provide Validation sign off for PV
Manage supplier validation for non-electrical pack components
Ensure all Certification/Regulation Compliance testing is completed
PDT representative for all ADV related issues
Participate in DFMEAs & DRBFMs
Review Engineering changes in E2 to ensure validation requirements are comprehended and updated in the existing ADV plan
Provide validation status reports to pack PDT, propulsion Core ADV, Battery Core PDT, and other customers as needed
B.S. Engineering
Highly knowledgeable of laboratory testing processes
Understanding of engineering theory and principles of automotive energy storage systems
Time management skills to meet agreed upon customer deliverables, able to manage multiple projects at one time
Appropriate interpersonal styles and communication methods to work effectively with local and international product development partners to meet mutual goals
Technical writing ability to create written engineering evaluation reports
Ability to read, interpret and generate engineering drawings and specifications
Quick learner, able to handle planned and unplanned work, and able to handle multiple projects
2 years of HV battery experience OR 2 years of lab test and development experience
High voltage or electrified vehicle safety training and hands on work experience
Working knowledge of battery test methods including GMW 16390 and GMW 3172
May be considered as a technical expert for use of certain tests/equipment including battery cyclers, environmental chambers and voltage, current, temperature and pressure measurement equipment
DFSS training
RED X training

231

Compnent Validation Engineer Resume Examples & Samples

Review electrical component hardware and software design requirements
Specify supplier validation deliverables in sourcing documentation
Coordinate development of Environmental and EMC test plans
Set-up serial data testing review meeting
Request supplier software test plan and execution rollout
Notify Subsystem Validation Engineer (SVE) when software is available for testing
Review and approve data from ENV, EMC, Diagnostic, Serial Data and Software testing
Sign-off appropriate documentation when validation is complete
Communicate electrical component validation status
Strong level analytical ability where problems are unusual and complex
Strong level of interpersonal skills to work independently and effectively with others
Knowledge of engineering software and systems as it pertains to job-related area
BSE, BS in Electrical Engineering or Computer engineering

232

System Validation Engineer Resume Examples & Samples

Working with CPUs, boards, software and power validation engineers/architects to define strategies and test plans to validate power consumption, power efficiency and performance for Intel silicon and server platforms
Responsible for test plan development/execution and first level debug
Responsible for lab management inventory control and automatic data acquisition tools
Participate in correlation efforts of pre-si power subsystem assumptions and characterization work
Responsible for developing automation software for validation/characterization of electronic circuits
Responsible for the development/enabling/execution/tuning of complex workloads for different server segments

233

Senior Validation Engineer Resume Examples & Samples

Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance
Travel (approximately 10%) domestic and/or international
Must be able to plan and lead validation and qualification activities for multiple complex projects of any size, which may be regional or global in scope and are occurring at the same time, ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICON and the FDA
Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors. These activities include Installation Qualification (IQ); System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control
Must be able to conduct meetings for a Risk Impact Assessment (RIA), Validation Risk Assessment and 21 CFR Part 11 Assessment
Must be able to create a User Requirements Specification, and assist in the creation of a Functional
Extensive experience in computer system validation, preferably in clinical systems
Must have a solid background in hardware and software required to produce a network topology diagram and to ensure that all installation steps are present in an IQ Protocol
Considerable knowledge of software development life cycles
Must be experienced in serving as technical liaison between end users and testers
Proficient with 21 CFR Part 11, ICH guidelines, and FDA regulations on computer system validation
Excellent interpersonal, written, and verbal communication skills; flexible; works well on a team; strong problem solving ability; good project management skills and excellent collaborative skills
Ability to work independently on all assignments, meets deadlines, and provides guidance to lower level validation personnel
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees location, the employee may be required to possess a valid Driver’s License

234

System Validation Engineer Coop Resume Examples & Samples

Highly integrated programmable chip level designs - FPGA design and VHDL coding required to enable device pre-proto FPGA emulation testing
C/C++ FW development for SOC validation
Application level Tcl/Tk scripting for automated control of the test systems
High speed board design using PMC and third party IC's, involving both analog and digital circuitry
You will work as part of a team to develop, execute and document a series of Feature Tests that will fully validate the operation of the prototype SOC as part of the overall system. These feature tests will exercise the various functional blocks of a prototype IC, associated FW/SW and tests the system level circuitry to performance criteria and to industry standards
Troubleshoot and resolve complex problems in embedded multi-core real-time systems

235

Senior Validation Engineer Resume Examples & Samples

Collaborate with product Quality Engineering/Product Operations to track and evaluate environmental bioburden and product bioburden monitoring results for quarterly microbiology assessments
Maintain single use sterilization validation procedures and ensure procedures and practices are in compliance with US and international standards
Provide guidance to engineering teams, device reprocessing teams, and manufacturing teams in the selection of sterilization methods, sterilization cycles and locations, manufacturing locations, and the establishment of sterilization product families. Ensure new products (and/or product changes) sterilization validations protocols are compatible with Operations requirements and constraints
Manage annual revalidation of EO sterilization processes
Collaborate with Quality Engineering for quarterly dose audit and revalidation of Gamma sterilization processes
Establish and maintain sterilization procedures of single use products in accordance with validated sterilization process
Optimize sterilization control processes, systems, and procedures to support growth in production volumes, addition of manufacturing sites, addition of sterilization locations and increase in product lines. Develop systems and processes which are robust and reflect industry best practices. Develop requirements and workflow for information technology tools for managing sterilization control
Adapt existing protocols or create new protocols as required to document sterilization test procedures
Evaluate manufacturing changes for effects on or from sterilization. Support Operations in cost reduction and consolidation projects associated with sterilization processes
Manage sterilization re-validation activities with external organizations and laboratories
Perform compliance audits for external facilities as required
Provide engineering support for resolution of terminal sterilization issues
Evaluate cleanrooms and assist manufacturing with cleanroom configuration to address bioburden alert level notices and optimize product cleanliness
Support interactions with regulatory bodies as needed in the area of sterilization
Act as technical mentor both internally to Operations teams and external partner organizations
Terminal sterilization modalities: EO, Radiation, Low Temperature (STERRAD®, Steris)
Environmental monitoring, microbiological testing, and sterilization processes for single-use products
Working knowledge of AAMI TIR 12, TIR30, ISO 11135, ISO 11137, AAMI TIR 28
Hands-on engineering skills with the proven ability to work well in a team environment and drive individual projects
Knowledge of engineering design control systems, e.g. Agile preferred
Superior written and oral communication and documentation skills
Proficiency with standard business software (MS Office)

236

Software / System Validation Engineer Resume Examples & Samples

Bachelor Degree in Electrical Engineering, Computer Science, or related discipline with 3+ years of work experience, a Masters in Electrical Engineering, Computer Science, or related discipline with 2+ years of work experience, or related discipline
Must have at least 5 years of experience in the following
3+ years of experience and demonstrated knowledge of Python, TCL, and BASH or other shell scripting
3+ years of experience in and ability to review/understand programming including Python, TCL, BASH, and C/C++
3+ years of experience with software debugging/problem solving and time management skills
2+ years of experience and knowledge of computer architecture, system network architecture, platform architecture, and validation architecture
2+ years of experience and working knowledge of the Linux and Windows operating systems

237

System Validation Engineer Resume Examples & Samples

Minimum B.S. in Electrical Engineering / Computer Engineering / Computer Science with minimum of 5 years of working experience in silicon validation
Familiar with protocols - Ethernet and PCIe
Good knowledge in high speed IO electrical characterization
Good understanding and experience of debugging with a logic analyzer or a software debugger, protocol analyzer, Ethernet tester and other lab equipment

238

Validation Engineer Resume Examples & Samples

Main function: ASIC lab bringup, characterization, debug and trouble shoot
Wireless SoC HW validation using FPGA or HW emulation
ASIC Verification
Require BSEE with 2 to 10 years of relevant industrial experience
Require excellent ASIC bringup and lab debug experience
Prefer lab equipment automation experience
Prefer ASIC debug experience with firmware and system HW engineers
Prefer low power SoC experience
Require good understanding ASIC RTL design and verification experience in
Require good understanding ASIC RTL design and verification experience in IP and SoC development

239

Validation Engineer Resume Examples & Samples

You manage automation validation of (parts of) projects
You participate in project team meetings and report status validation engineering
You manage the hours foreseen for your different tasks, and report hour status
You always look for improvements in documents and discuss improvements with different departments
You have review meetings with different departments in Wommelgem regarding validation aspects: project management, project engineering, software engineering, etc
You have review meetings with the world-wide customers as part of automation validation audit, discuss validation plans and validation documents

240

Production & Validation Engineer Resume Examples & Samples

Minimum 2 years’ experience in validation
Experience from R&D, production within Medical Devices, Pharmaceutical or similar is required
Experience with clean room validation is a merit

241

Validation Engineer Resume Examples & Samples

Responsiblefor preparing, executing and/or reviewing validation deliverables. Such itemsmay include the following: start-up procedures, commissioning documents,validation protocols and reports (IQ, OQ, PQ, process validation, cleaning validation, etc.), development reports,acceptance testing protocols. May also assist in the production of userrequirements, specifications, standard operating procedures and otherdocumentation required for the completion of the validation
Responsiblefor understanding complex technical and analytical systems including HMI, PLCand other software based equipment systems in order to provide test plans andacceptance criteria for validation
Responsiblefor providing technical support and technical expertise to team to facilitateresolution of system and quality issues, either from direct experience or fromavailable source materials
Responsiblefor review of engineering changes to assess validation requirements, costs andresources. Decisions directly impactcompliance
Strongability to manage multiple andmore complex tasks with confidence
Support ofall performance management initiatives
Improve workmethods by analyzing methods and procedures to ascertain the most efficient wayto perform all tasks
Monitor andmaintain a deep understanding of variables impacting key performance metrics,contributing input and support to team in achieving targets
Performother related duties, projects and analysis as assigned by Director
Managebroader, more complex supply chain projects as assigned
Assistwith mentor ship / training of maintenance and engineering personnel invalidation expectations, protocol development, and execution strategies
SubjectMatter Expert for environmental monitoring enterprise wide

242

System Validation Engineer Resume Examples & Samples

Conduct HIL, vehicle testing on test courses and public roads, including overseas location. Activities involve function check of test system and field data collection
Generate test result report and communicate with development team, providing details of issues encountered in the field
Proactively work together with global team, both remotely and directly in overseas locations

243

Validation Engineer Resume Examples & Samples

Excellent telephone and written communication skills with proven prior experience
Working knowledge of US regulatory submission
Proficient with computer programs desirable; or an aptitude to learn computer programs as needed
Resourceful and well organized
Have general math skills; adding, subtracting, multiplication, division and percentage calculation

244

Analog Validation Engineer Resume Examples & Samples

5 years work experience with some analog/digital and/or RF design/testing experience, including participation in high-volume silicon development programs
Hands-on experience with validation of silicon IC, with emphasis on analog/digital area
Hands-on experience with equipment: oscilloscopes, , Spectrum Analyzer, signal generators, VNA, logic analyzer, programmable power supplies, etc
Understand of basic electronic circuit knowledge like Ohms law
Basic coding/scripting skills, like C, C++, LabVIEW, Matlab, Excel ect
Preferred Experiences

245

System Validation Engineer Resume Examples & Samples

You want to be part of an exciting, dynamic, and challenging work environment, requiring rapid and constant learning and skill development
You have a systematic approach to problem-solving within a team and on your own. When something isn't working properly, it's important to you to figure out why
You have excellent analytical, communication, and documentation skills
You are interested in designing sophisticated electronic hardware and systems
You have experience at work or school with FPGAs and digital design
You have experience at work or school with software development languages, preferably C/C++, Python or TCL
You have used a variety of test equipment in a lab environment
You have 1 to 3 years of relevant professional or co-op work experience
You have a Bachelor's Degree in Electrical and/or Computer Engineering, or equivalent
Experience with PCB design and schematic capture
Experience with SystemVerilog
Experience configuring and working in Linux
Experience with lab equipment such as oscilloscopes and multimeters
Experience developing and executing test cases, and documenting the results
Knowledge of OTN and Ethernet communication protocols, as well as Interlaken and PCI-Express

246

Dram Validation Engineer Resume Examples & Samples

Experience in silicon validation automation
Excellent hardware and software debugging skill
Programming experience in C, Tcl, Expect, Python…
Good background in computer architecture
Basic knowledge in Bench tools (Oscilloscope, Logic Analyzers, Power Analyzers…)
Basic knowledge in DRAM cell architectures, DRAM memory organization and periphery design for low DRAM power
Experience on system level DRAM validation
Basic knowledge in memory test patterns

247

Validation Engineer Resume Examples & Samples

Provide technical expertise and guidance for the preparation and execution of validation protocols and reports
Review and troubleshoot anomalies, deviations, etc
Resolves and consults on applicable validation compliance and manufacturing process issues
Mentor and leads projects
Provide technical reviews of protocols
Contribute at the validation project team level for validation activities
Assist in developing and providing technical training
May provide guidance to less senior staff
May work with hazardous materials
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Perform other duties & projects as assigned
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
10+ years related experience
Experience related to validation of in-vitro diagnostic device and medical device manufacturing processes
Experience in analytical and physical test methods and their respective validations
Comprehensive knowledge of validation documentation
Advanced knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR
Train and direct lower level staff
Able to work with a variety of people on multiple tasks
Demonstrate problem-solving and troubleshooting skills
Organized and detail oriented
Knowledge and ability to use MS Office and other manufacturing systems

248

Senior Validation Engineer Resume Examples & Samples

Author and when required review validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports
Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems
Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes
Lead risk assessments when required. Participate to risk assessments & risk management teams
Review change control documents, to evaluate impact on qualified systems and validated processes
Subject Matter Expert, SME, for Computer System Validation, (including data integrity)
Manage validation projects; including managing time, resources and budgets; own associated change controls
Develop and justify the validation approach based on risk and a scientific rational
Co-ordinate qualification and validation execution activities, including external vendors and internal departments
Maintain procedures governing validation to ensure they are in compliance with Corporate policies and regulatory requirements
Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation
Establish and maintain effective relationships with internal team, customers and suppliers
Provide mentoring and leadership to Manufacturing Technical Services team
LI-NSI
BS degree in Life Sciences, Computer Science, Chemistry, Engineering or equivalent
Minimum 5 years experience in validation
Minimum 2 years experience in managing validation projects
Familiarity with current international regulatory regulations, cGxP requirements and best practises, including 21 CFR part 11, 210 and 211, Annex 11 to EU-GMP guidelines and GAMP
Computer System Validation (including data integrity) would be an advantage
Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems
Good communication skills in English & French with facility, production, laboratory, technical operations, QA, and outside vendor groups

249

System Validation Engineer Resume Examples & Samples

Candidate must possess a Bachelor's or Master's Degree in Computer Science, Computer Engineering, Electrical Engineering, or any other related field
C and C++ programming
CPU Architecture
Experience in FPGA and software development

250

Validation Engineer Resume Examples & Samples

1) Silicon validation plan development
2) Test cases development with C/assembly language
3) Validaiton board design, including schematic and layout according to requirement per project
4) RTL coding and implement with FPGA

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Validation Engineer Resume Examples & Samples

Validation Engineer Resume Examples & Samples

Validation Engineer Resume Examples & Samples

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Validation Engineer Resume Examples & Samples

System Validation Engineer Resume Examples & Samples

Validation Engineer Resume Examples & Samples

Validation Engineer Resume Examples & Samples

How to Make
a Resume

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Resume Tips

200+ Action
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