CSV Engineer
United Consulting Hub
We are seeking a CSV Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotech environment. Key Requirements Hands-on experience with Computer System Validation (CSV) Strong understanding of GAMP 5 and 21 CFR Part 11 Experience supporting QC laboratory systems and/or manufacturing equipment validation Ability to develop and review validation lifecycle documents (URS, IQ, OQ, PQ, Risk Assessments, Validation Reports) Experience working cross-functionally with QA, Manufacturing, Engineering, and IT teams Strong documentation and communication skills Key Responsibilities Develop, execute, and maintain CSV documentation and validation protocols for QC and manufacturing systems Perform risk assessments and ensure compliance with GAMP 5, 21 CFR Part 11, and GMP requirements Review and support validation lifecycle activities, including URS, IQ, OQ, PQ, and validation reports while collaborating with QA, Manufacturing, and IT teams #J-18808-Ljbffr
Vacancy posted 4 days ago
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