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
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
- 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
- Site expansion, greenfield, or brownfield project experience
- FAT/SAT coordination and startup validation exposure
- Background in pharmaceutical, biotech, or CDMO manufacturing environments