Sr Lead CQV and CSV Engineer

Senior Validation Lead, CQV / CSV

We are seeking a Senior Validation Lead with strong experience supporting GMP qualification and validation programs across manufacturing equipment, facility utilities, QC laboratory systems, and computerized systems. This role should be capable of leading end-to-end validation lifecycle activities, authoring and reviewing validation deliverables, coordinating cross-functional teams, and ensuring compliance with FDA, cGMP, GAMP 5, 21 CFR Part 11, and data integrity expectations.

Key Responsibilities Lead commissioning, qualification, and validation activities for GMP manufacturing equipment, cleanrooms, utilities, and laboratory systems.
Develop, execute, and review validation lifecycle documentation, including Validation Plans, URS, Risk Assessments, Design Qualification, IQ/OQ/PQ protocols, traceability matrices, deviations, and final reports. Support Computer System Validation for laboratory and enterprise systems such as Empower...