Sr Lead CQV and CSV Engineer

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.

• Lead commissioning, qualification, and validation activities for GMP manufacturing equipment, clean rooms, 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, LIMS, ELN, Veeva Vault, Track Wise, Kneat, and related GxP platforms.
• Coordinate validation work with Engineering, QA, Manufacturing, Facilities, Automation, QC Laboratory, and Project Management teams.
• Support FAT/SAT, calibration verification, qualification execution, discrepancy resolution, deviation investigation, CAPA, and change control.
• Apply risk‑based validation practices aligned with ISPE, ASTM, GAMP 5, FDA 21 CFR Part 11, ALCOA+, and GMP requirements.
• Support qualification of equipment and systems such as freezers, isolators, biosafety cabinets, bioreactors, blenders, CIP/SIP skids, RO skids, HVAC, cold rooms, warehouse temperature mapping systems, chromatography systems, and QC laboratory instruments.

• 8+ years of validation experience in pharmaceutical, GMP manufacturing, or QC laboratory environments.
• Strong CQV background across equipment, utilities, facilities, laboratory instrumentation, and computerized systems.
• Hands‑on experience with IQ, OQ, PQ, FAT, SAT, risk assessments, deviations, CAPA, and change control.
• Strong CSV experience with regulated laboratory and quality systems.
• Experience with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, ALCOA+, cGMP, and GLP expectations.
• Ability to lead validation execution independently and manage multiple stakeholders.

• Empower, LIMS, ELN, LabX, Chem Station, OMNIS Veeva Vault, Track Wise, Kneat, MS Project or similar project tracking tools.

The ideal replacement is not just a protocol executor. They should be a validation lead who can own documentation strategy, drive execution, resolve discrepancies, interface with QA and Engineering, and support both CQV and CSV work streams in a regulated life sciences environment.