Biotech and Pharmaceutical, Brownfield Redevelopment, Commissioning, Current Good Manufacturing Practice (cGMP), Document Management, GMP (Good Manufacturing Practices), Manufacturing, Process Validation, Regulatory Compliance, Startup, Support Documentation, System Test, Validation Documentation, Writing Skills
LOCATION
Indianapolis, IN
POSTED
30+ days ago
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