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CSV Engineer

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Katalyst Healthcares & Life Sciences

Raritan, NJ (In Person)

Full-Time

Posted 1 week ago (Updated 1 day ago) • Actively hiring

Expires 6/12/2026

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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
Education & Experience :
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 Ability to lead teams & manage multiple projects

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