Lead CQV Engineer

Katalyst HealthCares & Life Sciences

Concord, NH

Job Description

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

Apply

Vacancy posted 2 days ago

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