CQV Engineer - Eli and Lilly Company

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CQV Engineer - Eli lilly and Company
Indianapolis, IN (Onsite)
12-Month Contract
No H1B and CPT
Possiblity 2nd round On-site

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 7 hours ago

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