validation analyst Jobs

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Senior Technical Strategist

V.L.S. Systems, Inc

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Lansing, Michigan, USA

Contract

Role: Senior Technical Strategist Location: Lansing, MI Hybrid Duration: 12 Months with possible extension Interview: Phone/MS-Teams/F2F Top Skills & Years of Experience: - 5+ years of IT project management experience, preferably supporting large, complex technology initiatives. - 5+ years providing Independent Verification and Validation (IV&V) or equivalent quality assurance services. - Bachelor's Degree in Information Technology, Business Administration, Project Management, or a related fiel
Easy Apply
Posted 1 day ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 6 days ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Framingham, Massachusetts, USA

Full-time

Responsibilities: Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing trace matrix to ensure requirements are tested to meet the software intended use. Preparing risk assessment for functional requirements and providing testing. strategy, implementing technical & procedural controls as part of mitigation. Preparing SOP/Work instruction for equipment and software-based systems. Requirements: 6 to 8 years of Non-Product Software
Posted 22 days ago | Updated 2 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 22 days ago | Updated 2 hours ago

Validation Engineer

AdientOne LLC

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California, USA

Contract

Role: Validation Engineer Location: Santa clara USA 95054| Onsite Duration: 6+ months contract Job Description: In this role, this engineer will be part of a highly technical team that develops test plans, completes functional & electrical validation, & debugs issues for memory controller, NOC & other silicon interface features. Executes electrical & functional test plans for client processors using hardware & software validation tools, oscilloscopes, & logic analyzers. Debug of electrical &
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Posted 14 days ago | Updated 8 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Schaumburg, Illinois, USA

Full-time

Responsibilities: Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations). Bachelor's degree or equivalent experience in computer science, information technology, or a related field. High degree of proficiency in Microsoft Office Suite and Smartsheet. Detail-oriented with a strong analytical mindset and problem-solving capabilities. Excellent project
Posted 22 days ago | Updated 2 hours ago

Validation Engineer

Shimento, Inc.

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Portsmouth, New Hampshire, USA

Contract

Title: Analytical Validation Specialist IV Location: Portsmouth, NH Long Term Oniste Lead validation activities for analytical equipment, including software updates, new installations, and decommissioning.Act as Subject Matter Expert (SME) for analytical systems across Quality Control, Manufacturing, and other departments.Plan and execute validation protocols (IQ/OQ/PQ) for equipment and system changes.Manage and maintain TW records, including Change Controls, CAPAs, and Deviations.Create and r
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Posted 34 days ago | Updated 20 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Cincinnati, Ohio, USA

Full-time

Responsibilities: Develop Project Plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP). Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems. Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program. Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, function
Posted 22 days ago | Updated 2 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S
Posted 13 days ago | Updated 2 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

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Kansas City, Missouri, USA

Full-time

Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manager. Engage
Posted 20 days ago | Updated 2 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 22 days ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Rockford, Illinois, USA

Full-time

Responsibilities: Perform validation activities to ensure compliance with government and customer requirements. Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches. Maintain existing validated processes, coordinating internal and customer approvals as needed. Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals. Assist in the change control pro
Posted 22 days ago | Updated 2 hours ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

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Waltham, Massachusetts, USA

Full-time

Responsibilities: Local Validation Program Maintenance. QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. V
Posted 22 days ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Maple Grove, Minnesota, USA

Full-time

Responsibilities: Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures. Provide project estimates independently. Review estimates for Engineer I's. Submit specification, protocol and report for approvals and documentation control vi Change Request. Develop
Posted 22 days ago | Updated 2 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the
Posted 9 days ago | Updated 2 hours ago

Sr. Computer system Validation Engineer

Katalyst Healthcares and Lifesciences

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Saint Joseph, Missouri, USA

Full-time

Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports). Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manager. Enga
Posted 22 days ago | Updated 2 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in establishing standard quality and validation pract
Posted 22 days ago | Updated 2 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in
Posted 22 days ago | Updated 2 hours ago

Technical Strategist - Hybrid(Face to Face Interview in Lansing, MI)

Zeforge LLC

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Lansing, Michigan, USA

Contract, Third Party

Top Skills & Years of Experience: - 5+ years of IT project management experience, preferably supporting large, complex technology initiatives. - 5+ years providing Independent Verification and Validation (IV&V) or equivalent quality assurance services. - Bachelor's Degree in Information Technology, Business Administration, Project Management, or a related field required. Preferred Skills: - Project Management Professional (PMP) certification. - Certifications such as Certified ScrumMaster (CSM)
Easy Apply
Posted 1 day ago

Validation Lead with SAP

Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Responsibilities: To create| assign and track the project [module] work plans for delivery and provide technical guidance for work completion. Ensure process improvement and compliance in the assigned module| and participate in technical discussions/review. Create work plans| monitor and track the work schedule for on time delivery as per the defined quality standards. Prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations. Develop and guide
Posted 22 days ago | Updated 2 hours ago