Lead CQV Engineer / Lead Validation Engineer

Lead CQV Engineer / Lead Validation Engineer

on-site, full-time in Devens, MA.

J.D:

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:
  • Drawing walkdowns
  • Equipment and component verification
  • 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

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