Lead CQV Engineer / Lead Validation Engineer

Introduction:

This position is for a Lead CQV Engineer or Lead Validation Engineer who will be responsible for leading second shift CQV execution activities across multiple systems and workstreams. The individual will coordinate daily execution priorities, interface with various departments to resolve issues in real time, oversee the execution of protocols, and support validation 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
  • 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

Requirements:

Required Skills:

• 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)

Additional Requirements:

• 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