Lead CQV Engineer

Responsibilities

• Lead second shift CQV execution activities across multiple systems and workstreams.
• Coordinate daily execution priorities to recover schedule slippage and maintain timelines.
• Interface with QA, Engineering, and Operations to resolve issues in real time.
• Oversee execution of IQ/OQ protocols and operational verification activities.
• Support and review drawing walkdowns.
• Support and review equipment and component verification.
• Support and review Materials of Construction (MOC) and weld verification.
• Provide oversight for temperature mapping and validation activities.
• Support SIP/CIP and related cycle development activities as needed.
• Ensure all documentation meets GMP/GDP and audit-ready standards.
• Drive deviation identification, escalation, and resolution.

Requirements

• Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred).
• 8+ years of CQV/validation experience in pharma or biotech.
• Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF).
• Proven experience leading validation teams or shift-based execution efforts.
• Strong GMP/GDP knowledge.
• Experience with eVal (required); ValGenesis a plus.
• Experience with temperature mapping (Ellab a plus).