Computer System Validation Engineer
Bothell, Washington, United States
Job Description
Job Summary:
Roles & Responsibilities:
Requirements / Qualifications:
- We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing Execution Systems (MES) in a pharmaceutical or biologics manufacturing environment.
- The ideal candidate will have expertise in CSV lifecycle management, GAMP, 21 CFR Part 11, protocol development and execution, and cross-functional collaboration to ensure compliance with regulatory and quality requirements.
Roles & Responsibilities:
- Lead and execute Computer System Validation (CSV) activities for GxP computerized systems and applications throughout the validation lifecycle.
- Develop, review, execute, and maintain CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, Validation Summary Reports, and SOPs.
- Support the validation of Manufacturing Execution Systems (MES) and ensure compliance with internal procedures and regulatory requirements.
- Partner with Business Owners, Technical Owners, Quality Assurance (QA), Manufacturing, Engineering, and IT teams to develop validation deliverables and system requirements.
- Assist with User Acceptance Testing (UAT) by supporting protocol execution, documenting test results, investigating test failures, and ensuring testing complies with established procedures.
- Develop system requirements and specifications for computerized systems used in GxP manufacturing operations.
- Perform risk-based validation activities in accordance with GAMP methodology.
- Ensure compliance with cGMP, GxP, GAMP, SDLC, and 21 CFR Part 11 regulations governing computerized systems and electronic records.
- Support change control, incident management, and system lifecycle activities using IT service management tools.
- Collaborate with cross-functional teams to resolve validation issues and maintain audit-ready documentation.
- Provide on-site support throughout User Acceptance Testing (UAT) execution.
Requirements / Qualifications:
- Bachelor's degree in Life Sciences, Engineering, Information Technology, Computer Science, or a related discipline (or equivalent industry experience).
- 4+ years of experience in Computer System Validation (CSV) within a GxP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
- Strong hands-on experience with Manufacturing Execution Systems (MES) validation (e.g., Emerson Syncade).
- Strong understanding of Computer System Validation (CSV) principles and validation lifecycle activities.
- Experience developing and executing CSV documentation, including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional/Design Specifications
- Risk Assessments
- IQ/OQ/PQ Protocols
- Validation Summary Reports
- Traceability Matrices
- Standard Operating Procedures (SOPs)
- Strong knowledge of GAMP 5, 21 CFR Part 11, cGMP, GxP, SDLC, and Good Documentation Practices (GDP).
- Experience with User Acceptance Testing (UAT), protocol drafting, execution, and defect management.
- Familiarity with ERP systems (e.g., SAP, Oracle) and Electronic Batch Records (EBR) systems (e.g., InfoBatch).
- Experience with Quality Management Systems (e.g., Veeva) and IT Service Management tools (e.g., ServiceNow).
- Knowledge of pharmaceutical manufacturing, laboratory systems, and biologics manufacturing processes.
- Excellent technical writing, communication, problem-solving, and cross-functional collaboration skills.
- Ability to work independently while managing multiple validation activities in a fast-paced, regulated environment.
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Career Focus: Validation
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