Lead CQV Engineer / Lead Validation Engineer, Onsite in Devens, MA

Lead CQV Engineer / Lead Validation Engineer

This role requires the ability to be on-site, full-time in Devens, MA.

Lead Validation 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: 
o    Drawing walkdowns
o    Equipment and component verification
o    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
Job 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)
•    This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends