KH
Lead CQV Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Staff / Principal
1 month ago
- GMP
- SIP
1 month ago
Not enough detail in this posting to match
- 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.
- 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.
- 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.
Lead CQV Engineer · Katalyst Healthcares & Life Sciences