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CQV Engineer

3B Staffing LLC

Indianapolis, IN
CQV Engineer (Onsite -IN)

12-Month Contract


We are supporting a major pharmaceutical site expansion and are looking for an experienced CQV Engineer to join an onsite team in greater Indianapolis , Indiana . This is a long-term contract opportunity with hands-on execution responsibilities in a GMP manufacturing environment.


Key Responsibilities

  • Execute Commissioning, Qualification, and Validation (CQV) activities onsite
  • Perform IQ/OQ execution for cGMP equipment and systems
  • Author, route, execute, and approve validation documentation using KNEAT
  • Conduct equipment and system testing; document results electronically in real time
  • Generate test scripts, acceptance criteria, and traceability deliverables
  • Manage deviation documentation and resolution within digital workflows
  • Maintain inspection-ready validation packages in compliance with GMP standards
Required Experience

  • Hands-on CQV execution experience in GMP manufacturing environments
  • Strong working knowledge of KNEAT digital validation platform
  • Experience executing IQ/OQ (PQ exposure a plus)
  • Ability to support documentation-heavy validation projects
Preferred (Nice to Have)

  • Site expansion, greenfield, or brownfield project experience
  • FAT/SAT coordination and startup validation exposure
  • Background in pharmaceutical, biotech, or CDMO manufacturing environments
Apply
Vacancy posted 3 days ago
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