CSV Engineer
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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.Requirements: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.