Lead CQV Engineer
Katalyst CRO · Concord, NH · 1 mo ago
HybridEngineeringContract
Responsibilities
- Drawing walkdowns
- Equipment and component verification
- Materials of Construction (MOC) and weld verification
- 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
- 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.