CQV Engineer (Onsite IN)

Business Needs Inc

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profile Job Location:

Indianapolis, IN - USA

profile Monthly Salary: Not Disclosed
Posted on: 9 hours ago
Vacancies: 1 Vacancy

Job Summary

CQV Engineer (Onsite -IN)

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
Additional Details
  • Location: Onsite -Greater Indianapolis Area Indiana (LP2 facility)
  • Duration: 12 months
  • Start Date: TBD
CQV Engineer (Onsite -IN) 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 envir...
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