Lead CQV Engineer

About the role

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.

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)

Schedule

• This role is for 2nd shift
• Must be able to work second shift (2–10 PM EST) and weekends