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...
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
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