What are the responsibilities and job description for the Lead CQV Engineer / Lead Validation Engineer position at Stellent IT LLC?
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.