Sr Lead CQV and CSV Engineer

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, LIMS, ELN, Veeva Vault, TrackWise, Kneat, and related GxP platforms.
• Cookordination 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.

Required Experience

• 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.

Preferred Systems / Tools

• Empower, LIMS, ELN, LabX, ChemStation, OMNIS Veeva Vault, TrackWise, Kneat
• MS Project or similar project tracking tools