Unknown Company

Lead CQV Engineer

tulsa, ok • Posted 1 weeks ago
Onsite Full Time Architecture
  • 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.
  • 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.

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.
  • 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.

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).
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Lead CQV Engineer in tulsa at Unknown Company

This position is listed as full time and onsite.

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