Validation Lead Resume Samples
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Validation Lead Resume Samples
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SJ
S Jacobs
Santos
Jacobs
86950 Rowe Club
Phoenix
AZ
+1 (555) 872 0806
86950 Rowe Club
Phoenix
AZ
Phone
p
+1 (555) 872 0806
Experience
Experience
Philadelphia, PA
Lead Validation Technologist
Philadelphia, PA
Ortiz-McDermott
Philadelphia, PA
Lead Validation Technologist
- Documents all corrective actions taken when test systems deviate from the laboratory's established performance specifications
- Manages the Medical Technology student laboratory rotations and visitors and establishes schedules
- Trains medical technologists in new testing procedures; assists with implementation of newly developed clinical tests
- Ensures pending logs and worksheets are performed in a timely manner
- Performs proficiency testing in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations
- Reviews daily technical work and results
- Assists with ensuring that procedure manuals are up to date and that annual reviews of procedure manuals are conducted
San Francisco, CA
Lead System Validation Engineer
San Francisco, CA
Rolfson, Kemmer and Gutkowski
San Francisco, CA
Lead System Validation Engineer
- Providing the validation input into the program specific SORs- Appendices C2, VCRI, System Technical Specification (STS), and G2
- Provide the validation input into the program specific system SORs- Appendices C2, VCRI, System Technical Specification (STS), and G2
- Develop and coordinate System ADV plans across features and systems
- Performing read across for validation testing
- Providing validation subsystem and component expertise to System Engineering Teams
- Feature FMEA- create validation procedures based on failure modes
- Developing validation designs and overall system level validation plan. Designs, authors, and reviews product test procedures
present
Boston, MA
Lead Subsystem Validation Engineer
Boston, MA
Streich-Gaylord
present
Boston, MA
Lead Subsystem Validation Engineer
present
- Create and manage vehicle and/or commodity ADV sub-plans
- Lead / support evaluation procedure development
- Develop and coordinate LADV plans across features and systems
- Frequent contact with others outside of work group
- Provide the validation input into the program specific system SORs- appendix C2 VCRI and
- Manage export validation activities in foreign countries with local partners
- Participate in DFMEA work groups
Education
Education
Bachelor’s Degree in Computer Science
Bachelor’s Degree in Computer Science
Southern Illinois University Carbondale
Bachelor’s Degree in Computer Science
Skills
Skills
- 5-10 years’ experience in relevant area (validation design/release /development, leader roles) for Chassis Steering Components [Steering Column, Intermediate Shaft, Front of Dash Seal, Steering Gear, and Rear Steering Gear]
- Interest and ability in systems integration; basic understanding of vehicle dynamics, chassis controls, NVH
- High level of analytical ability to attack problems that are very unusual and extremely difficult, comfortable with ambiguity
- Highly developed oral and written communication skills
- Ability to translate lesson learned into validation plans
- Demonstrated ability to manage broad program complexity- multiple architectural variants
- Understanding of engineering theory and principles of design; mechanical/ electrical system /controls
- Familiarity with design/release function, physical test, CAE, and development
- Chassis Steering [Steering Column, Intermediate Shaft, Front of Dash Seal, Steering Gear, and Rear Steering Gear] or Vehicle validation experience
- Collaboration with downstream Subsystem Validation Engineer to allow for successful sourcing and validation of components and systems for production
15 Validation Lead resume templates
Read our complete resume writing guides
1
Validation Team Lead Resume Examples & Samples
- 21 CFR Part 11 experience
- BSEE/BSCS or equivalent Technical Degree
- Expertise in quality reviews
- Experience as a Verification and Validation Engineer for 5+ years
- Detail oriented and meticulous worker
- Good organizational skills in recording test results
- Strong knowledge of validating products based on SaaS, cloud-based technologies
- Strong belief in quality compliance and following rules
- Knowledge of testing medical products
- Knowledge of FDA regulations required to test medical products
- Cloud, Virtualization, KVM, VMWare
- Integration test frameworks such as Cucumber, Selenium
- Application server middleware (e.g. WebSphere Liberty, Oracle WebLogic)
- 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 testing Software, Web Applications, System Components, and Database
- 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
2
Validation Lead Resume Examples & Samples
- Experience in authoring, reviewing executing and approving validation documents
- Interface with Quality organization and the ability to defend rationale in validation documents
- Ability to review and analyze data
- Experience assisting with instrument support and/or qualification activities
- Proficiency in utilizing documentation system to author protocols and reports
- Experience participating in teams and collaborative work environments
- Good communication skills (verbal and written), math skills, general computer skills
- Team environment a must
- E Doc experience with a working knowledge of templates, workflows and approval process
- Strong root cause analysis with cGMP experience
3
Automation Technical Lead-solution Validation Services Team Resume Examples & Samples
- Bachelor's or Master's Degree in computer science/engineering or a related field
- Expertise in Python, C, JSON, XML
- Deep background in Continuous Integration / Continuous Deployment techniques
- You have hands-on experience in Network Design, Network Solution Validation, and or Network Automation
- Experience with developing software/scripts as needed to assist in the systems validation process
- Hands on with one of the following cloud computing platforms: Amazon Web Services (AWS), Google Cloud, Rackspace Cloud, Microsoft Azure, etc
- Experience with provisioning and configuration management tools such as Puppet, Chef, cobbler, or Juju
- You should have some experience with scripting languages such as Perl, Python, or Bash. Python experience is strongly preferred
- Familiarity with cloud computing concepts including virtualization, web services API's, elastic infrastructure, distributed data storage (database, block, object), multitenancy, and metered usage patterns
- Familiarity with basic networking protocols and concepts (TCP/IP, VLANs, subnetting) is required
- You have an excellent working knowledge of Linux. Experience with multiple distributions (Red Hat, Ubuntu, etc), networking (bonding, bridging, iptables, vlans, OVS, etc), virtualization (KVM, libvirt, etc), and server software (Apache, NFS, MySQL and/or Galera, MongoDB, etc) are all strongly desirable
- You will be able to quickly ramp up on new technologies outside of comfort zone and think at scale
- You have excellent team and people skills and should be comfortable working in geographically dispersed teams
- You use problem solving techniques to identify, scope, and resolve difficult, intermittent, and other technical issues at scale
- Experience with block, file, and object storage systems such as Swift, Ceph, SAN, NAS is a plus
- Experience with Cisco IOS, NX-OS, and Nexus is a plus
- Familiarity with L2 overlay technologies such as VXLAN or NVGRE is a plus
4
Verification & Validation Lead Engineer Resume Examples & Samples
- Responsible for management and reporting of Product Integrity Assurance activities on the projects. This task includes (but not limited to)
- Provide technical guidance to resolve technical issues
- Reporting of progress against plan and budget
- Coordination of management reports and KPI's for all PIA activities
- Attendance at key project meetings such as mcrs and weekly engineering project review
- Identification of resource requirements of the internal PIA functions and work with PIA function heads to secure resource
- Escalation of any issues that are preventing delivery of the PIA commitments
- Responsible for ensuring that the V&V Strategy is implemented correctly on the project. Work with the Lead engineers from RAMS, Design Assurance & Approvals, Verification Services and software Quality Assurance to ensure that plans are developed that deliver the V&V Strategy and support the project milestones
- Ensure that the PIA project deliverables requested are well defined and communicated to the team
- Provide an interface between the PIA function and other Bombardier functions, engineering and non-engineering, to ensure that the critical inputs required in order to deliver on our commitments are clearly communicated and received on time
- Work with the design assurance and safety teams to ensure timely delivery of the approvals and acceptance of the product, including interface to NoBo, DeBo and AsBo. ensure the alignment of activities of the design assurance and safety teams to avoid duplication and maximise efficiency of the function
- Be the primary PIA interface to the Customer and external Stakeholders, develop and maintain a relationship with the customer ensure that the acceptance process can be implemented effectively and in accordance with the project schedule
- Engineering Degree in relevant technical area
- Technical domain, System Integration, System Architectural experience and understanding is essential
- Provide cost and schedule estimates on complicated engineering programs
- Provide technical expertise in one or more of the following areas: Validation & Verification, Authorisation & Acceptance processes or RAMS
- Be able to demonstrate the ability to use this technical knowledge in the support of other departments (engineering, production, procurement, projects) and the development of less experienced engineering personnel
5
TOS Operations Services QAF Validation Lead Resume Examples & Samples
- Validate that new control issues are reconciled with the existing control environment (i.e., assess adequacy of existing control inventory)
- Prepare and execute testing plans for Operations issues prior to closure and manage escalations to senior management as required
- Test remediation effectiveness and provide assurance that planned remediation mitigates identified risk prior to TOS leadership assertion of closure
- Coordinate with QAF Leads, RCA Managers, Business Control Managers, and others to develop and maintain the evidence collection schedule based on remediation milestones and closure schedules
- Prepare testing memo and coordinate executive report out of testing/validation results to Chief Risk Officer
- Maintain validation metrics/reporting and coordinate distribution of status reports
- Facilitate evidence retention and access for auditors and other interested parties
- 10+ years experience in audit, testing, compliance or related risk/issue management roles
- Considerable knowledge of applicable laws, regulations, financial services and regulatory trends
- Excellent communicator comfortable challenging senior stakeholders and operating at all levels of the organization
- Ability to work in a fast-paced, deadline-driven environment
- Previous leadership over medium to large complex project initiatives
- Strong proven analytical and problem-solving skills
6
Process Validation Lead Resume Examples & Samples
- Leading, organizing and motivating local validation team
- Assuring an adequate organization and team structure
- Assuring aligned resource management within the Department while taking into account internal User Requirements as well as Quality and GxP guidelines,
- Contributing to continuous improvement and International standardization for topics related to process validation,
- Supporting small, mid size and big projects within the plant,
- Participates in audits of other facilities and assists other facilities in their validation efforts. May host regulatory agency audits and present validation topics
- Managing and developing employees and potential leaders within the Department,
- Assuring the ability to meet the Department goals in respect to Quality, Fullfilment and EHS
- Excellent communication skills, fluent in english (written and spoken)
- Familiar with Quality Management and GxP Regulations
- Knowledge of Validation Methodologies
- Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
- Knowledge of the manufacturing processes
- Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel
- Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines
7
Lead Equipment Validation Engineer Resume Examples & Samples
- Ensure that relevant and compliant documentation is generated, as required, by site SOP, company policy, and international cGxP regulations with little supervision
- Contribute to the generation and review of required documentation (such as SOP’s, qualification protocols) to support the facilities/equipment requirements
- Oversee contract validation services engineering projects (facilities, major equipment installations; master planning, project oversight)
- 30%
- Provide adequate reporting and communication of all projects
- May supervise activities of technicians and/or other engineers
- Manage the development and implementation of procedures for the validation of equipment, processes and systems to ensure compliance with regulatory agency requirements, internal company standards, and current industry practices
- Interact with customers in a professional manner during project scoping, audits, and problem resolution
- Must have knowledge of current industry expectations of validation requirements for process validation, cleaning validation, computer validation, and equipment qualification
- Ability to handle multiple projects and deliver on aggressive project timelines with little supervision
- Ability to determine, present, and defend in a professional manner project requirements/status
- Must have knowledge of all current cGMP requirements in the US and other parts of the world
- Ability to communicate clearly to all levels (operator to senior management) within the site
- Must be able to utilize Microsoft Office
- Understanding of statistical evaluation tools
- Experience leading and directing validation resources
8
ACT Transfer Lead, Validation Architect Resume Examples & Samples
- Responsible for the design, implementation and sustainability of manufacturing processes at Alere sites worldwide, with a focus on ensuring proper manufacturability is built into product and process designs
- Leads complex cross-functional transfer projects for new products and process improvements to meet project, company and organizational goals
- Leads formulation of validation strategies and plans for new products and process improvements at the feasibility stage to guide subsequent development and transfer planning; resident validation expert for the ACT group
- Reports status of projects to Senior Director of ACT, project Directors and project stakeholders by using established project management methods; escalating issues which cannot be resolved by the team
- Provides facilitation and technical leadership in the generation of project technical content, including specifications, studies and reports
- Provides technical expertise on biological, chemical, process and equipment capability issues as they relate to new or existing equipment, processes and devices
- Provides subject matter expertise in the design, development and validation of formulations, processes and analytical test methods
- Ensure documentation is complete and meets defined requirements
- Leads utilization of quantitative risk assessments in validation and project planning
- Possesses a working application/knowledge of medical device regulatory requirements and standards
- Identifies opportunities for process improvements
- Minimum of 15 years’ experience in new product introduction of Medical Device Products
- Excellent conceptual, analytical, and problem-solving ability
- Experience with Design for Manufacturability and Assembly (DFMA)
- Good communication skills, both verbal and written, and the ability to effectively interface within a cross-functional team environment
- Experienced in modern manufacturing principles and techniques
- Ability to influence and manage at all levels
- Ability to manage resource, time, budget, and people is required
- Must have the ability to work cross-functionally with teams
- Knowledge of and compliance with applicable Quality System requirements (e.g., FDA, ISO & MDD) and experience working in a regulated environment is preferred
- Good presentation skills to deliver updates and/or presentations effectively to a variety of audiences are required
- Excellent computer skills – Minitab, JMP, word processing, and spreadsheets
- This position may require up to 50% Domestic and International travel
- Six Sigma Black Belt Certification is preferred
- Proven application of data analysis and statistical techniques (especially DOE) is preferred
- Knowledge and experience in CGMP requirements and preferably FDA and ISO 9000 requirements is preferred
- Knowledge of LEAN methodologies is a plus
- Knowledge of Reliability Engineering concepts and/or experience is a plus
- Prince2 or PMP (Project Management Professional) certification is a plus
9
Lead Vital Validation Engineer Resume Examples & Samples
- Point of Contact with India Validation team to provide direction from Melbourne site
- Up to 25% Travel required to India for training & business coordination
- Executing manual and automated tests, including test debugging, submitting change requests for defects, and formal recording and reports of test results
- Ensuring documentary evidence for the portion of the test program for which they are responsible is developed, archived under CM control, and meets certification requirements
- Escalating unresolved quality and safety issues to the project team and possibly safety committee
- Ensuring compliance of the project with the defined processes governing validation testing
- Establishing the project schedule and ensuring project execution of commitments, including identification and escalation of risks
- At minimum Bachelors Degree of Science Degree in Engineering or Computer Science
- At least 5+ years of experience in an engineering position
- Prior test script experience with National Instruments TestStand
- Experience with GE Test Processes and product domain
- Min 2 years experience of Alstom OnBoard platforms
- Effective team building and problem solving skills
10
Lead System Validation Engineer Resume Examples & Samples
- The development and execution of robust validation plans that comprehend vehicle level features and systems that drive cross-functional requirements and integration, including regulatory compliance
- Defining validation criteria and methods for vehicle level feature/system definition and functionality to meet performance requirements
- Feature Technical Specifications/ System Technical Specifications
- BS in Electrical Engineering, Mechanical Engineering or equivalent
- Experience with Electromechanical Systems
- Knowledge of calibration development
- Excellent knowledge of the Vehicle Development Process
- Subsystem/Component Validation experience
- Automotive development experience preferred
- Understanding of HIL test methods
- Infotainment experience
- Experience (10+ Years) or demonstrated proficiency with Performance engineering
- 5+ Years of Controls experience
- 5+ Years of Active Safety experience
- DFSS Greenbelt. Blackbelt preferred
11
IS Business Analyst & Validation Lead Resume Examples & Samples
- Develop and maintain validation expertise of IT systems
- Ensure that the validation strategies are compliant with the current regulatory and industry standard
- Lead development of validation protocols (IQ, OQ, PQ)
- Support execution of validation protocols
- Support deviation follow-up to ensure closure of actions
- Support process with timely closure of audit observations items
- Support change control activities and provide support for re-validation activities
- Understand and participate in all levels of the system development life cycle (SDLC)
- Escalate, communicate and manage issues not resolved
- Understand and integrate Shire IS standards and policies
- Assist in support of production systems
- Participate to on–call service
12
Integration Verification Validation & Test Lead Resume Examples & Samples
- 8+ years demonstrated engineering leadership experience
- Ability to manage time and resources of the team to meet assigned deadlines
- Experience specifying test verification requirements
- Direct experience in creating test cases, plans and procedures
- Hands on experience in integrating and conducting system tests for large, complex software systems
- Experience in mission management, planning and scheduling, satellite telemetry and control, and software information assurance
- Experience in prioritizing and resolving discrepancy reports
- Experience in satellite control ground programs and mission management
- Strong analytical and problem solving abilities
- Ability to work with a mixed customer set that includes government, subcontractors, and peer contractors
- Demonstrated ability to effectively work with and communicate with all levels of leadership and individual contributors on the program team
- Active TS/SCI security clearance
- Experience working on a program using Earned Value Management
- Experience in cost estimation and proposal development
- Engineering functional leadership experience
- Qualified Raytheon Six Sigma Specialist or equivalent
13
Validation Test Lead With Life Sciences Domain & Oracle EBS Resume Examples & Samples
- Oracle Agile PLM
- Serialization
- Regulatory Applications
- Oracle EBS
- Veeva or Salesforce or other SaaS Applications
- Argus
14
Test & Validation Lead Engineer Resume Examples & Samples
- Creates and releases the overall project test strategy (including other disciplines). Responsible to consolidate, monitor and drive other disciplines to ensure on time execution of test related activities (coordination of all validation schedules)
- Aligns all domain test schedules and consolidates into overall project test schedule. Maintains throughout the project
- Organizes the definition of regression strategies with the domain test managers and ensures necessary test coverage
- Monitors and reports the overall project test status including internal and customer level tests
- Monitors and reports linking of test cases to technical requirements. Drives domains as needed for on time completion
- Actively manages test progress including driving for solutions and ensuring successful on time execution
- Serves as primary interface (internal & customer) for project test related matters
- Prepares the Test & Validation product release recommendation including project test report
- Responsible contact for all tasks within the organization towards the validation and vehicle application within the project
- Agreement of necessary milestones and deliveries within the project team towards other stakeholders as well as towards the customer
- Development of efficient and effective approach together with all other involved stakeholders within the projects
- Bachelors Degree in Engineering Discipline
- 2 years of Test and Validation or Technical Project Management Experience (ex. SW, Product, Vehicle, Algorithm, HW Testing)
- Managed projects as Validation responsible
- Experience with Automotive Electronic/Electromechanical Products
- Good communication skills within the team, internal & external customers a must
- Willing to travel to support internal and external customers
- Willing to work offsite for some assignments
- Great (English) oral and written communication skills
- Able to work in a team environment and be flexible with changing priorities
- Able to multitask to meet project timing (time management skills)
- Proficient with Microsoft Office Tools (Microsoft Project) and other organizational tools
- Work independently with little to no supervision to meet tight deadlines
- Good logical problem solver; good attention to detail
- 5 years of Test and Validation or Technical Project Management Experience (ex. SW, Product, Vehicle, Algorithm, HW Testing)
- Managed multiple projects in parallel as the main Validation responsible/interface
- Excellent (English) oral and written communication skills
15
Verification & Validation Team Lead Resume Examples & Samples
- Demonstrable skills in leading teams and developing process efficiencies
- Current Microsoft server and desktop application security
- VMWare security
- Database security (e.g., Oracle, MS SQL, MS Access)
- Border device security (e.g., firewall, VLANs, IP Subnetting, Ports and protocols)
- Encryption standards
- Auditing (e.g., system accounts, security logs, system and network anomalies)
- Technical writing – technical documents and user training materials
- Ten (10) years of demonstrated Cyber security experience
- Four (4) years of demonstrated aggregate experiences involved in detailed design, installation, and configuration of IT systems and networks in accordance with DoD cyber security policies (e.g., DoDI 8500.2) and DISA STIGs, to include the configuration and use of security products
- Four (4) years of demonstrated aggregate experience monitoring application and system security configurations and auditing IT systems and networks for compliance with DoD Cyber security policy
16
Lead Systems Validation Engineer Resume Examples & Samples
- Responsible for the development and execution of robust validation plans that comprehend vehicle level features and systems that drive cross-functional requirements and integration, including regulatory compliance
- Leads defining validation criteria and methods for vehicle level feature/system definition and functionality to meet performance requirements
- Lead/Create test procedures for all Feature Technical Specifications/ System Technical Specifications, including performance requirements
- Support System Engineers in defining interface requirements across SMTs and Integration areas
- Responsible to work with and coordinate validation activities across multiple SMT areas as required by features/system
- Provides validation subsystems and components expertise to System Engineering Team in order to successfully meet program deliverables. Single point contact to help leverage appropriate subsystem/component expertise
- To collaborate with System Engineers in defining requirements and interface across domains; while utilizing Global TIEs in the development of validation methodology and procedures for system requirements
- Participates in system DFMEA, Verification &Validation plans & Fault Tree Analysis and incorporates findings and learnings into LADV plans. Drive system failure mode understanding into validation plans
- Provide the validation input into the program specific SORs- Appendices C2, VCRI, System Technical Specification (STS), and G2
- Perform read across for validation testing
- Participate in feature/system technical reviews for assigned features/systems
- Participate in resolution of issues involving interface engineering and validation
- Mentor others to grow organizational capabilities
17
Validation Steering Team Lead Resume Examples & Samples
- Proven leadership abilities in cross functional organization, with 5+ years of experience in program/project management skills
- Prior experience in managing pre-silicon and post-silicon validation is preferred
- Organized, highly motivated and energetic
- Has with excellent problem solving skills, communications skills and ability to manage customers' interactions
- Bachelor's degree in Electrical/Electronic Engineering, Computer Engineering, Computer Science or higher
- Experience with test and validation equipment is an advantage
18
Computer Systems Validation Lead Resume Examples & Samples
- Bachelors and 8 years of CSV experience required or 4 years CSV experience with a Master’s degree in Computer Science ,Informatics or equivalent required
- In-depth knowledge of SDLC (System Development Lifecycle) required
- Experience in computer system validation required
- Knowledge of regulatory safety reporting databases required
- Experience with DOCSPACE or standard documentation system preferred
- Experience with MedDRA preferred
- Experience with SAS/JMP required
- Previous pharmaceutical experience preferred
- Problem solving abilities and skills
- Clear concise documentation skills
- Demonstrated understanding of basic statistical principles required.IT Compliance
19
Lead Quality Computer System Validation Resume Examples & Samples
- Responsible for providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects
- Perform pre and post review and approval of validation test scripts including test defects
- Review/approval of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use
- Ensure a high degree of Inspection Readiness for Systems in Q-CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within Q-CSV responsibility
- Act as backup project management staff as needed
- Participate in audits, approves audit non-conformity action plans
- Demonstrates an understanding of many relevant Quality and Compliance principles and their applications
- Work with the Q-CSV Manager in developing, monitoring and managing project costs, schedules, resources and quality
- Leads and mentors a team of internal and external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices
- Assist or drive status meetings to communicate and address project risks or issues
- Works collaboratively with project teams to keep them informed of project status, including any barriers
- Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
- Defines internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management
- Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
- Provide an environment which encourages the company's credo and diversity of opinions and thoughts
- Ensure timely completion of assigned training and expense reporting
- An Associate’s Degree is required
- A Bachelor’s degree in Computer Science, Information Systems, Business Administration, the Sciences or other related field is a plus; additional certifications a plus
- A minimum of 5-7 of progressive experience in the Pharmaceutical / Medical Devices/ Biotech, Consumer Industry with direct experience in Computerized System Validation activities and QA Analysis is required
- Preferred experience with R&D systems (pharma, consumer and/or medical device) supporting Clinical, Regulatory Affairs, Non-Clinical/Preclinical and Product Development business areas
- The Q-CSV Lead is responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams
- This position will support internal and external Health Authority regulatory audits
- Knowledge of SDLC Quality Management process and Computerized System Validation principles is required
- Working knowledge of SDLC, GAMP 5, is highly desirable
- Thorough knowledge of cGMP / GxP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211, part 58 and Part 820 and ICH E6 and/or E8 is required
- Working knowledge of Global regulations like ICH, MHRA, OECD, Annex 11, ISO preferred
- Experience in Testing Management Tools like HPALM is preferred and document management tools like Documentum, Veeva
- Superior written and oral communication and excellent Microsoft Office skills required
- Must have the ability to work effectively in a highly matrixed, virtual systems environment
- Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
- Strong skills in interdependent partnering and influencing required
- Expert organizational skills are Preferred
- Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding Quality
- Experience interacting with health authorities and/or notified bodies during inspections is preferred
- Understanding of how regulatory bodies approach inspections and how to respond to Health Authority observations is preferred
- Knowledge of process design, development and continual improvement is desired
- Knowledge of process improvement experience such as Six Sigma, Lean and Design Excellence is a plus.Compliance Security
20
Software Lead Verification & Validation Resume Examples & Samples
- Bachelors degree required; Engineering degree preferred
- 10+ years of experience in Verification & Validation for Web/PC based applications
- Strong Experience in Requirement based testing - Integration, System testing & Test Automation
- Experience with automated test tools such as Microsoft Test Manager (MTM), Smart Bear, Test Complete, CPP unit, Junit, JBehave or Cucumber and automated test patterns
- Strong skills in at least one of the following languages - C#, C++
- Experience writing clear and concise bug reports, test plans, and test cases
- Sound Knowledge and experience with process frameworks (CMMI, Agile, SCRUM) including requirements management, defect tracking, build management, change management, and configuration management tools
- Excellent interpersonal and communication skills, particularly with respect to written and oral communication, including the ability to explain technical concepts
- A high degree of aptitude, creativity, and self-direction is required. Work independently to tight deadlines
21
Team Lead Loads & Validation Resume Examples & Samples
- Lead a team of international highly skilled engineers (coaching, recruiting etc.)
- Overall responsible for team operations and performance within load assessments, aero-elastic analysis and load verifications according to technology development, onshore and offshore product portfolio plans
- Overall responsible for associated tools and release of turbine models and templates for further use throughout the organization
- Develop strategies, methods, processes and plans for future load assessment responsibilities
- Team development and ensuring the right competencies and skills are available, shared and strengthened
22
Validation Test Lead With Life Sciences Domain & Opsm Resume Examples & Samples
- 9 - 12 years of Experience in Life Sciences, Computer System Validation
- Must possess hands on experience and understanding of
- GAMP 5 Risk Based Validation
- Functional Risk Assessment
- GXP Assessment
- 21 CFR Part 11 Assessment
- Data Migration Qualification
- Disaster Recovery Qualification
- Qualification and Commission
- Validation coverage in IQ, OQ and PQ
- Deviation management process
- CAPA
- Validation Summary Reports
- Knowledge on Infrastructure IQ & qualification
- Experience/practical understanding of OPSM (Oracle Pedigree Serialization Manager) testing
- Good functional knowledge on Oracle Inventory, and Manufacturing modules especially of Oracle Process Manufacturing
- Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
- Must possess formal training/certification on Testing & Validation
- Excellent communication skills
- Excellent technical writing skills
- Should be able to work independently with minimum supervision
- Should have worked in cross-functional environments and comfortable to liaison with business
- Proficiency Legends
23
Embedded SW Verification & Validation Lead Resume Examples & Samples
- Good Programming skill in C, C++/ C#
- Good knowledge in OOPS
- Good experience in Embedded software for V&V. (HW and SW knowledge and debugging)
- Good exposure in different levels of testing (Unit, Integration, System, etc.,)
- Good experience in Black box and White box testing
- Expertise in Analyzing, designing, Creating and executing test cases
- Experience in writing test specifications, test plan etc.,
- Good Written and Verbal communication
- Good exposure to all phases of Software development life cycle
- Good knowledge in test automation tools like Jenkins, etc.,
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Propulsion Systems Lead System Validation Engineer Resume Examples & Samples
- Understanding of writing, debugging, testing and releasing software for automotive embedded systems
- Self-Motivated - Able to work independently effectively
- Excellent organizational and documentation skills
- Knowledge of the Global Vehicle Development Process, specifically Validation ADV deliverables (Including Hardware and Software attributes) and VDP major milestones/Relating definitions
- Ability to work with limited data and make effective decisions always putting customer 1st
- Willingness to work non-standard hours and do global travel when required
- Understanding of roles and responsibilities of interfacing counterparts primarily in Validation, Design Release, Suppliers & Supplier Quality
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Group Lead, Validation Resume Examples & Samples
- Responsible for setting and achieving department objectives/schedules while working across multiple departments
- Leads a group of Validation Scientists/Engineers to perform and implement projects which have direct effect on company profitability. Includes development of direct reports, providing feedback and performance evaluation
- Manages the efforts of direct reports to execute large scale projects in a cGMP environment. Includes preparation of project cost estimates, timelines, and resource requirements
- Assists in the preparation of proposals and bid packages to secure validation contractor services. Tracks spending on approved contractor/project purchase orders
- Plans, communicates, and manages scientifically sound validation strategies large scale multi-facetted, multi-site projects
- Effectively schedules and communicates with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regards to validation study execution/testing requirements and status of assigned execution activities
- Able to Anticipate, recognize and trouble shoots problems associated with validation studies, equipment, and procedures
- Guides direct reports in the preparation validation project plans, protocols, and test equipment
- Guides direct reports in the evaluation of test data for conformance to protocol acceptance criteria and/or to investigate and determine root cause of validation study discrepancies
- Guides direct reports in the preparation of detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria
- Responsible for Subject Matter Expert (SME) review of Validation and Engineering Qualification protocols and reports for adherence to cGMPs, good documentation practices, and general quality oversight
- Responsible for review of Deviations, Change Controls, Material Change Controls, Document Change Controls as an SME for Validation
- Provides technical support/training to Validation department personnel and other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed
- Researches governmental regulatory requirements and industry guidance on assigned projects
- Develops validation programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements
- Supports the facility in internal and external inspections
- Communicates with other CSL sites to gain insight and share Best Practices for assigned areas of responsibility
- Provide input on facility layout and design from a validation perspective as required
- Other tasks as required by Department Management
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Lead System Validation Engineer Resume Examples & Samples
- 8 or more years of experience with the validation of wireless devices (including handsets or telematics modules)
- Knowledge and understanding of telematics features and services from a system-level, “end to end” perspective
- A well-developed understanding of the theory and principles of wireless technologies (LTE, GSM, etc.), circuit switched and packet switched connections, and the theory and principles of operation of the internet and packet data protocols
- Demonstrated technical and professional skills to launch a product employing the use of wireless telephony technologies (i.e. LTE, GSM)
- Ability to manage complex projects within tight timelines
- Experience with drafting complex test plans and product validation strategies
- High level analytical ability where problems are unusual and complex, with a demonstrated ability to root cause product and/or system level failures
- Exhibits appropriate interpersonal, written, and verbal styles and communication methods to work effectively with internal and external business partners and suppliers to meet mutual goals
- Able to effectively coordinate the activities of others
- Strong understanding of GM OnStar product features and functionality on both a module and system level
- Experience in validating and launching GM OnStar telematics hardware/software products
- MS in Electrical Engineering or equivalent
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IT ERP Validation Lead Resume Examples & Samples
- An university degree
- (Bio) Pharma experience (min 5 y)
- Focused on quality & eye for detail
- Proactive & Hands-on behavior
- Solution oriented, good problem solving skills
- Insist on rules & approaches & able to communicate / defend them
- Strong communication & coordination skills
- Capacity to analyze business needs through a strong analytical mindset
- Validation knowledge & audit defense experience
- Systems Development Life Cycle background
- Good level of English is required
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Team Lead Validation Engineering Resume Examples & Samples
- You manage the validation department and validation aspects of ongoing projects
- You participate in department team meetings and report status validation engineering
- You manage the validation department capacity
- You manage the Way of Working within validation engineering, and you keep validation engineering procedures and work instructions up to date
- You are always looking 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, …
- You have review meetings with the customers worldwide as part of validation audit, discuss validation plans and validation documents
- You have review meetings with other GEA departments outside Wommelgem to standardize validation across GEA sites
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Qualification / Validation Engineer Lead Resume Examples & Samples
- Provide CQV leadership, vision, technical guidance, and performance management
- Provide Project Management expertise, including, but not limited
- Broad and in-depth knowledge of current validation approaches, methods, and protocols to evaluate equipment, systems, facilities and utilities
- 10+ years of CQV experience in the life sciences industry
- Ability to work well with diverse, multi-disciplined groups
- Ability to communicate project issues in an effective manner that leads to resolution
- Ability to effectively communicate with fellow project team members
- Knowledge of US FDA and EU EMEA regulations
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Turn-by-turn Functional Lead Validation Engineer Resume Examples & Samples
- Develop and execute Global Navigation map and POI validation test procedures including ground truth analysis.
- Identify and develop the framework for collecting and analyzing Global Navigation POI address point data
- Improve address search results for General Motors navigation systems, utilizing map extent geocoding
- Lead Root Cause Analysis on defects related to map and POI data content for General Motors Navigation Systems
- Identify systemic issues within the geocoding engine and POI search engine. Work with suppliers on solutions to improve performance
- Select appropriate regression test cases to be run for software / hardware releases
- Review test results, and write new test cases if necessary for new content
- Performs design analysis
- Defines automation system needs and acts a key liaison with automation tool development team to ensure projects are defined and executed accurately and in a timely fashion
- Executes in-vehicle and bench testing including manual and automated testing
- Ensures all tests results are reported promptly and accurately
- Lead a group of system test engineers in validating the turn-by-turn feature
- Meet team deadlines for product development and production timing
- Manages team’s workload priorities and identifies roadblocks to group lead or manager
- Communicates, coordinates, and consults with engineering departments and suppliers
- Develops strong relationships with design release and development teams
- Anticipate and communicate validation roadblocks or challenges
- Support testing at outside test facilities when needed with suppliers
- Travel as required for validation
- Minimum 3 years professional experience
- Understanding of in-vehicle networking protocols such as CAN, LIN, MOST, etc
- Experience with common electrical test equipment (meters, oscilloscopes, automotive bus tools, etc.)
- Extensive knowledge of automation test environments
- High level analytical ability where problems are unusual and complex
- Exhibits appropriate interpersonal styles and communication methods to work effectively with business partners
- Hight level of professional integrity and personal accountability
- Experience with automotive electrical system
- Experience with PC driven test equipment and systems
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Lead Subsystem Validation Engineer Resume Examples & Samples
- Develop plans and schedules
- Develop criteria and requirements
- Prepare & conduct tests
- Report ADV status
- Support Quality processes
- Lead / support evaluation procedure development
- Capture and submit best practices, lessons learned and customer surveys
- Manage export validation activities in foreign countries with local partners
- Support vehicle validation - type approval activities
- Participate in problem solving teams
- Participate in DFMEA work groups
- Create and manage vehicle and/or commodity ADV sub-plans
- Review program/process results
- Document and update product/process knowledge
- Maintains frequent communication with system feature owners
- Prepares formal written test reports
- Work with Technical Integration Engineers to specify validation procedures and deliverables at key interfaces
- Ensure system level interface requirements are covered in validation plan and are assigned to the appropriate lead engineer and Subsystem Validation Engineer to execute
- Support System Engineers in defining interface requirements across domains
- Clear define a strategy to verify key safety metrics, consumer metric compliance and "robustness" to real world driving conditions on production process build vehicles
- Develop and coordinate LADV plans across features and systems
- Provide the validation input into the program specific system SORs- appendix C2 VCRI and
- Participate in system DFMEA, V&V plans and Fault Tree Analysis. Incorporate any findings and learning's into validation plans
- Own complete system level validation plan
- Participate in resolution of issues involving interface SMT’s and other subsystems.
- Manage validation complexity – understand all buildable combinations and permutations
- Facilitate all parties to escalate / resolve conflicts in feature vs feature tradeoffs, testable requirements and different subsystem limitations
- Ensure system level interface validation is conducted to the appropriate milestone deliverables- executed on time
- Provide status of LADV plan executions to System Validation EGM and appropriate PVE(s)
- Ensure completion of all associated documentation prior to PVCL
- Basic automotive knowledge
- Basic engineering principals
- Vehicle Physical Partition Structure
- Knowledge of practices and methods used to validate secure embedded systems
- Knowledge of common automotive communication protocols (e.g., CAN, FlexRay, MOST, and Ethernet)
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Lead Computer System Validation Engineer Resume Examples & Samples
- Project master validation planning
- Setting of project Computer System Validation (CSV) guidelines
- Setting of GDP, cGMP & GAMP project guidelines
- Quality review of design documentation
- Quality review of testing documentation
- Review of validation documentation
- Support development teams and provide need pre-qualification and verification testing
- Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives
- 6+ years of qualification and validation experience in a bioprocess commercial manufacturing facility
- Working knowledge of SDLC (GAMP)
- Strong interpersonal skills, including good technical communication
- Knowledge of governing regulations, specifically 21CFR211 and Eudralex Volume 4 Annex 11
- Experience with validation of DeltaV systems and equipment
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Telematics System Validation Lead-autonomous User Experience Resume Examples & Samples
- The development and execution of robust validation plans that comprehend vehicle level features and systems that drive cross-functional requirements and integration, including regulatory compliance
- Defining validation criteria and methods for vehicle level feature/system definition and functionality to meet performance requirements
- Support System Engineers in defining interface requirements across Integration areas
- Providing validation subsystem and component expertise to System Engineering Team
- Collaborating with System Engineers in defining requirements and interface across domains
- Participating in system DFMEA, Verification &Validation plans & Fault Tree Analysis
- Providing status of System ADV plan executions to Validation EGM and appropriate PVE(s)
- Performing read across for validation testing
- Participating in feature/system technical reviews as appropriate
- Participating in resolution of issues involving interface to other subsystems
- BS in Electrical Engineering, Computer Engineering, Mechanical Engineering or equivalent
- Solid understanding of telematics architectures and communication protocols
- Experience with Electromechanical Systems
- Knowledge of calibration development
- Knowledge of the software development process
- Excellent knowledge of the Vehicle Development Process
- Automotive development experience preferred
- MS in Engineering
- Infotainment experience
- Experience (10+ Years) or demonstrated proficiency with Performance engineering
- 5+ Years of Controls experience
- 5+ Years of Active Safety experience
- Understanding of HIL test methods
- DFSS Greenbelt. Blackbelt preferred
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Silicon Validation Technical Lead Resume Examples & Samples
- Typically requires at least 10 years total experience in the areas of silicon validation, board-level hardware design, or IC design
- Experience with design, simulation, debug, and performance analysis of analog circuits, voltage regulators, and power distribution for high-speed digital ICs
- Strong bringup and debugging skills and hands-on lab work. Experience with complex test equipment setups for analog measurement. Basic software automation skills in Python, Perl, C/C++
- Coordinate with IC designers to build knowledge of design internals within the validation team. Mentoring and training for junior validation engineers
- Effective communication skills working across large cross-functional HW, SW, architecture teams. Provide guidance on board-level HW design requirements, and contribute to ATE test and reliability test planning
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Lead System Validation Engineer Resume Examples & Samples
- Responsible for systems validation of a Chassis Steering feature or system [Steering Column, Intermediate Shaft, Front of Dash Seal, Steering Gear, and Rear Steering Gear], coordinating activities in multiple regions
- Responsible to work with and coordinate validation activities across multiple SMT areas as required by feature
- Responsible for coordinating and executing regulatory compliance for feature or system
- Support System Engineers in defining interface requirements across Integration/SMTs
- Support Validation TIEs in development of validation methodology for the system requirements
- Ensure system level interface requirements are covered in validation plan and are assigned to the appropriate Lead System Validation Engineer and/or Subsystem Validation Engineer to execute
- Develop and coordinate System ADV plans across features and systems
- Ensure optimized hardware plans in support of program-level LADV plans for system-level validation
- Provide the validation input into the program specific system SORs- Appendices C2, VCRI, System Technical Specification (STS), and G2
- Participate in system DFMEA, V&V plans and Fault Tree Analysis. Incorporate any findings and learnings into validation plans
- Participate in system technical reviews as appropriate
- Participate in resolution of issues involving interface SMT’s and other subsystems
- Provide status of System ADV plan executions to Validation EGM and appropriate PVE(s)
- Mentor Subsystem Validation Engineers as required
- Demonstrated high level of interpersonal skills to work effectively with others, motivate employees, and elicit work output; proven leadership skills
- Familiarity with design/release function, physical test, CAE, and development
- Understanding of engineering theory and principles of design; mechanical/ electrical system /controls
- Interest and ability in systems integration; basic understanding of vehicle dynamics, chassis controls, NVH
- Familiarity with manufacturing process and assembly operations and their effect on components/systems’ function
- Chassis Steering [Steering Column, Intermediate Shaft, Front of Dash Seal, Steering Gear, and Rear Steering Gear] or Vehicle validation experience
- High level of analytical ability to attack problems that are very unusual and extremely difficult, comfortable with ambiguity
- Demonstrated ability to manage broad program complexity- multiple architectural variants
- Collaboration with downstream Subsystem Validation Engineer to allow for successful sourcing and validation of components and systems for production
- Ability to translate lesson learned into validation plans
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Test & Validation Lead Engineer Resume Examples & Samples
- Support development of ADAS (Driving Functions) via Technical support of ADAS Quote Process and alignment of customer requirement specifications to internal requirements
- Definition of Validation Methodology by creating and releasing the overall project & system test strategy for ADAS (Driving Functions)
- Monitors and reports system as well as the overall project test status including internal and customer level tests
- Serves as primary interface (internal & customer) for Test & Validation and project test related matters
- Resource planning of test equipment and infrastructure for Test & Validation (including Driving Function)
- Engineering Bachelors Degree: Electrical, Electronics, Mechanical, Mechatronics
- 5 years of Test and Validation Experience: Vehicle and/or Bench Testing
- Detailed expertise on Driver Assistance System and its Sensorics
- Proficient with test related measurement technology (Vector Tools, etc) and programing tools such as: CAPL, C, visual basics, etc
- Knowledge in: system integration, conventional brake systems
- Experience with Automotive Electronic/Electromechanical Products and CAN/FlexRay/Ethernet communication bussystem
- Must be willing to travel to support internal and external customers
- Must be willing to work off-site for some assignments
- Able to multi¬task to meet project timing (time management skills)
- Familiar with MS Office
- Driver Education/Driver Training
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Lead nd Shift Validation Engineer Resume Examples & Samples
- Mentor and train other engineers on off-shift
- Responsible for creating standard work documents
- Represent 2nd Shift at shift carry-over meetings
- Work with Lab Engineers and Dynamometer Technicians, to monitor transmission validation testing in dynamometers during 2nd shift
- As issues arise, sort through dynamometer data to determine root cause of shut downs
- If possible, and the data supports, work to get test article back on test
- Document all issues at the test cells so that other shifts have the most accurate and up to date information available
- BS in Mechanical Engineering, Electrical Engineering, or equivalent
- Minimum two years engineering experience
- Dynamometer test experience
- Someone who challenges themselves and their peers
- Enthusiasm to apply understanding of physics and math concepts and the ability to put them into real applications
- Ability to think outside the box and challenge current process
- Ambition to get things done and overcome obstacles
- Familiarity with PUMA and INCA software
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Senior Embedded Verification & Validation Lead Resume Examples & Samples
- 6-8 years of Test experience in Embedded Systems
- Excellent Programming skills in C
- Experience of C#/C++ and OOPS Concepts
- Good in Data Structures and Pointers
- Defining test specifications at system or integration level
- Experience on test automation and continuous integration
- Debug test failures and analyze the root causes
- Automating test runs and reporting
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Lead of Validation & Procurement Resume Examples & Samples
- Assisting to develop and drive strategy and direction of the Delivery and Estate Management function
- Forging and developing relationships with Business Tower aligned partners, in addition to the InSv support teams in global locations
- Being part of the IDEM management team and as such, providing input into the wider team challenges
- Leading the transformation of the Validation and Procurement service in line with the O&T strategy
- Having accountability for developing the capability of the team, increasing skill level and right-first-time install rate
- Representing the Validation and Procurement function across O&T
- Good understanding of project disciplines (Prince, PMP, Agile)
- Good understanding of ITIL processes and associated concepts
- High degree of commercial awareness with sound understanding of key contractual obligations and risks to maximize benefits
- Ability to effectively build understanding of InSv technology strategy and direction and major IT initiatives, including awareness of the major roles and responsibilities of the IT function, in order to apply own up-to date technical knowledge
- Competent to discuss the underlying technology with a vendor, Build Teams and describe the overall IDEM function of several components in the technical platform
- Understands the design principles in the InSv products and all server hardware and can discuss specific technology application opportunities in own area
- Can identify and interpret key policies, standards and procedures affecting own area
- Must have a high degree of knowledge relating to the tools, techniques and services relevant to the organisation
- Must have a strong understanding of the server and database infrastructure components supported by the organisation. Must be able to identify which parts of the development lifecycle components and systems relate to
- Must have a good understanding of the medium and long-term plans and strategies of the organization; must have a good understanding of the operational and transformational activities across Barclays
- Must have a broad understanding of the business services provided and a broad knowledge of Bank products and services and understand how they all fit together
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Software Lead-system Verification & Validation Resume Examples & Samples
- Candidate should be able to independently work on technical tasks and support multi-disciplinary
- Customer satisfaction (VOC) - delivery performance, product reliability, organization responsiveness
- OTD and quality performance of work deliveries
- Bachelor’s degree (Electrical/Computers) Engineering required; preferably premier institutes like IIT, etc. Masters in Engineering is preferred
- 4+ years of experience in Electrical Domain, preferably in Power Systems area
- 6+ years of experience in Verification & Validation for Web/PC based applications
- Strong Experience in Requirement based testing - Integration, System testing & driving test automation
- Experience in planning, designing, and implementing testing strategies and automation infrastructure for large software system
- Experience with automated test tools like UFT, Selenium, Ranorex
- Strong skills in at least one of the following languages - C#, C++, Python
- Sound Knowledge and experience with process frameworks like (DFSS, CMMI, Agile, SCRUM) including requirements management, defect tracking, build management, change management, and configuration management tools
- Experience working with global teams and driving the projects for high customer satisfaction
- Experience as Scrum master is highly desired
- Experience driving requirements and leading project functionally is highly desired
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Project Lead-VP AML Scenario Management & Validation Resume Examples & Samples
- Practice established project management protocols including the development of project plans/timelines, facilitation of project meetings, ensuring project documentation is complete, consistent and of high quality, tracking the execution of tasks against the plans, etc
- Develop/support the written/verbal communication regarding identified risks; track issues and solutions and report them in a timely manner
- Prepare status reports for senior management and PMO – according to managed portfolio of projects
- Participate in the planning of Business As Usual (BAU) SMV activities
- Exercise complete oversight over the execution of SMV projects, from definition and planning, through execution and closure
- Act as a liaison with internal partners and customers to facilitate execution of SMV BOW
- Support creation of Capacity Plans and BOW
- Constantly monitor, proactively manage and report on progress, risks, issues, assumptions, dependencies and solutions of the project portfolio to all stakeholders
- Conduct and present project evaluations and assessment of results
- Work with the oversight committees to prioritize all initiatives
- Minimum 6 years of professional project management experience in Financial Services, preferably in multicultural environment
- Prior experience with large scale implementations
- Experience of working in an analytical or technical team is a significant advantage
- Experience in AML is a plus
- Working knowledge of AML policies and procedures is a plus
- Experience in writing business requirements is a plus
- Able to excel in dynamic, fluid, and continuously changing environment
- Proven ability to effectively prioritize and execute tasks, and work independently and collaboratively
- PMP and/or PRINCE 2 certification is preferred
- Strong Excel, PowerPoint & MS Project experience
- Proven people management skills; direct, project and/or matrix
- Excellent organizational skills, ability to multitask, and demonstrate flexibility
- Inquisitive, enjoys learning the mechanics of things
- Anticipate and respond to customer needs with action planning
- Complete requests on time with attention to detail
- Excellent corporate work ethics (timely, respectful and considerate to co-workers, honest)
- Must be a team player & work well under pressure
- Self-motivated/ability to work with limited supervision while still delivering all required results within given timelines
- Ability to take on multiple assignments and work independently
- Strong team player that can work effectively within multi-culture and complex work environments
- Ability to coordinate large-scale projects involving geographically and functionally diverse stakeholders
- Problem Solver, adaptive to change
- Ability to see big picture in a complex environment
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Automation Validation Lead Engineer Resume Examples & Samples
- Finalize the Automation Validation Plan
- Work with a team of engineers and System Integration (SI) contractors to complete all validation deliverables related to the Delta-V Manufacturing Control System (MCS) and Qualified Utilities Network (QUN)
- Give guidance on validation best practices for automation hardware, software and computer systems
- Follow FDA Title 21 CFR Part 11 for Data Integrity Compliance
- Draft, review or approve automation design and testing documents for all phases of testing (sFAT, Commissioning, Validation)
- Drive deviation resolution for all testing
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Lead Systems Validation Engineer Resume Examples & Samples
- Bachelor’s degree in engineering
- Understanding of writing, debugging, testing and releasing software (automotive embedded systems preferred)
- Excellent people skills – All levels of employment and significant cross-cultural
- Strong appetite for Technical leadership in a very diverse, fast-paced product environment
- Excellent organizational skills and strong ability to review/analyze technical documentation
- Ability to work with limited data and make effective decisions while always putting customer 1st
- Willingness to work non-standard hours (only as needed) and support global travel when required
- Understanding of roles and responsibilities of interfacing team members primarily in Validation, Design Release, Supplier Quality and the supplier community
- MS Degree EE or CE/CS Engineering
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Product Tagging Validation Team Lead Resume Examples & Samples
- Managing the workload of the team to ensure the delivery of results within tight deadlines
- Enhancing the business as usual process by improving validation efficiency and accuracy and ultimately converting it from a monthly into a daily process
- Over-seeing the development of code used to implement validation logic to ensure it is consistently applied and sufficiently documented
- Designing and producing Management Information to convey results and highlight issues to the PMRSC
- Managing Stakeholder relationships through regular interaction and co-operation, but always acting in the best interests of the Bank
- Managing operational risk by ensuring processes are documented and staff are cross-trained
- Developing your technical expertise and that of the team to ensure the team is sufficiently knowledgeable to face-off against technical experts in divisions outside of Product Control
- Producing presentations and communicating progress to Auditors and Regulators
- Supporting the development of an environment where people management and development is the number one priority. Coaching direct reports and others in the organisation, as appropriate
- Actively supporting the business strategy, plans and values, contributing to the achievement of a high performance culture
- Taking ownership for own career management, seeking opportunities for continuous development of personal capability and improved performance contribution
- Acting as a role model for new employees, providing help and support to facilitate early integration and assimilation of their new environment
- Supporting tough people decisions to ensure people performance is aligned with organisation imperatives and needs. Addressing individual performance issues, where necessary, to drive for high performance
- Previous experience managing a sizeable team or project
- Experience in dealing with Front Office business leaders
- Pricing and modelling of derivative products
- Programming experience in SQL, C++ (beneficial)
- Knowledge of front-to-back architecture of Investment Banks
- Educated to Bachelor’s degree level (or equivalent qualification / work experience)
- Association of Chartered Accountants (ACA), Chartered Institute of Management Accountants (CIMA), Chartered Financial Analyst (CFA) qualification or relevant Masters Degree (or equivalent)
- Strong derivatives product knowledge (beneficial)
- Control focused team leader with high attention to detail
45
Lead Validation Technologist Resume Examples & Samples
- Follows the laboratory's procedures for specimen handling and processing, test analyses, reports and maintains records of patient test results
- Assumes responsibility for and takes action regarding any quality control or quality assurance issues as it pertains to specific job duties. Maintains instruments and equipment in accordance with manufacturer's specifications
- Performs proficiency testing in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations
- Identifies problems that may adversely affect test performance or reporting of test results and either corrects the problems or immediately notifies the General Supervisor, Technical Supervisor, Clinical Consultant, or Laboratory Director
- In the Educational track: functions as an educator and provides instruction and training in theory, technical skills, safety protocols, and the application of laboratory test protocols to students, employees and residents
- In the Developmental track: assists in the validation/verification of new assays under the direction of the Medical Director. Performs validation/verification analysis, collects and analyzes data and prepares for Medical Director review
- Proactively recognizes and resolves complex technical problems and provides or seeks viable, appropriate solutions
- Clinical laboratory training or experience can be met by: 1. Medical technology internship 2. Full time experience performing non-waived testing for the required number of years 3. Part-time experience performing non-waived testing, with 2080 hours equivalent to one year
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Technical Lead-validation Resume Examples & Samples
- Test web applications in accordance with company guidelines and standards to improve product quality and verify that software meets specified requirements
- Create and implement system, regression and user acceptance test documents and execute the tests as required
- Produce regular reports on faults and issues found during a test cycle, with fault logging and developer allocation as required
- Liaison with developers and project managers on a day-to-day basis to correct and retest defects
- Create and maintain company-wide testing standards
- Knowledge of testing principles and processes for each stage of the project development life cycle
- Knowledge of developing testing documents (i.e. Test plan and Test Strategy document)
- Understanding of web standards (HTML5, XHTML, CSS3, Javascript and Flash) and validation tools
- Knowledge of and participation in an Agile environment (Scrum)
- Knowledge of bug tracking tools
- Experience of testing web applications
- Experience in creating manual test scripts
- Experience of public-facing web application testing
- Experience of cross-browser and cross-platform testing (Windows and Mac)
- Experience of testing web services
- Experience of testing against OWASP vulnerabilities
- Understanding of the principles of User Interface testing
- Understanding of Accessibility testing (JAWS)
- Knowledge of building automated test scripts
- Hands on experience with automated testing tools (Ranorex)
- Knowledge of scripting languages (Javascript, Python, Powershell) is an advantage
- Knowledge of server-side technologies C# and ASP.NET is an advantage
- Knowledge of databases (MS SQL Server preferable)
- ISEB/ISTQB certification or similar
- Experience in Social Media site interaction
