CSV Engineer

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 bility to lead teams & manage multiple projects