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Katalyst Healthcares & Life Sciences

Lead CQV Engineer

Pay: Not specified

Posted: 5 weeks ago

Location: Memphis, TN (Onsite)

Last Updated: 1 week ago

Hours: Full-Time

Expires: 10/4/2026

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What they do

A Validation Engineer evaluates and maintains machinery and equipment used in manufacturing, and supervises workers that use and repair the machines.

$99,941 / year median in Tennessee

+3% projected growth

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Job Description

Lead CQV Engineer Katalyst Healthcares & Life Sciences - 4.0 Memphis, TN Job Details Contract 18 hours ago Qualifications Project team coordination Good documentation practices (GDP) GMP Production filtration units Production validation processes Temperature monitoring Bioreactors Filtration Leading team collaboration initiatives Quality standards in production Liquid chromatography machines Pharmaceutical manufacturing facility experience

Full 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.

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.

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.