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CSV Engineer

Katalyst Healthcares & Life Sciences • Raritan, NJ, US • published 2026-09-29 02:55:16.066656

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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