Lead CQV Engineer

Karwell Technologies

  • Memphis, TN
  • 3 days ago
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    Skills

    • Biomedical Engineeringunmatched
    • Biotech and Pharmaceuticalunmatched
    • CIP (Clean-in-Place)unmatched
    • Chemical Engineeringunmatched
    • Chromatographyunmatched
    • Documentationunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Leadershipunmatched
    • Problem Solving Skillsunmatched
    • Process Validationunmatched
    • SIP (Sterilization-in-Place)unmatched
    • Software Testingunmatched
    • Team Lead/Managerunmatched
    • Temperature Mappingunmatched

    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.

    Numbers & Facts

    LocationMemphis, TN

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