CSV Engineer
Raritan, New Jersey, United States
Job Description
Roles & Responsibilities
- Lead end-to-end CSV activities (inventory → assessment → remediation → disposition)
- Support business separation for large GxP systems
- Define & implement risk-based validation strategies
- Review & approve test plans, UAT scripts, validation documents
- Ensure compliance with regulatory & quality standards
- Provide guidance, escalation & leadership to validation teams
- Collaborate with global & remote teams
- 7-10 years in CSV / Validation roles
- Experience in Pharma / Biotech / Medical Devices industry
- Proven experience in regulated environments (FDA/GxP)
- Strong expertise in CSV (Computer System Validation) in GxP environments
- Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation)
- Hands-on in Acquisitions / Divestitures / Business Separation projects
- Deep understanding of FDA regulations & GxP standards
- Experience with Risk-based validation approach
- Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs)
- Experience in UAT, Traceability Matrix & QA methodologies
- bility to lead teams & manage multiple projects
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