Lead CQV Engineer || Devens, MA - Onsite

Position:

Lead CQV Engineer location: Devens, MA -

Onsite Contract:

12+ months This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

Job Description:

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) Manoj Prajapati | Non-IT Recruiter An -

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