Biomedical Engineering, Biotech and Pharmaceutical, CIP (Clean-in-Place), Chemical Engineering, Chromatography, Construction, Documentation, GMP (Good Manufacturing Practices), Leadership, Problem Solving Skills, Process Validation, SIP (Sterilization-in-Place), Software Testing, Team Lead/Manager, Temperature Mapping, Welding
Job Description:- 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
Responsibilities:
- 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:
- 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
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Katalyst Healthcares & Life Sciences