CSV Engineer

Job Title: CSV Engineer

Location: San Francisco Bay Area, CA (Onsite 4 days/week)

Experience: 5 years

Job Description (Short JD)

• Lead Computer System Validation (CSV) activities for Medidata CTMS and other clinical applications.
• Author and execute validation deliverables including URS, FRS, Risk Assessments, Validation Plan, IQ/OQ/PQ scripts, Traceability Matrix, and Summary Reports.
• Ensure compliance with 21 CFR Part 11, GAMP 5, GxP, and internal QA procedures.
• Work independently with cross-functional teams (Clinical Operations, QA, IT, Vendors) to manage multiple validation projects.
• Perform impact assessments, system configuration reviews, and change control documentation.
• Support inspections and audits by providing validation evidence and documentation.
• Hands-on execution of validation scripts and documentation of objective evidence.
• Provide SME-level guidance for clinical systems validation and support lifecycle activities.

Top Skills Required (Short)

• Strong CSV expertise
• Medidata CTMS validation experience (must-have)
• IQ/OQ/PQ authoring & execution
• GAMP5, 21 CFR Part 11, GxP compliance

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