Overview
On Site
Contract - W2
Skills
GXP
Clinical
GAMP
CTMS
MEDIDATA
21 CFR
Job Details
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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