CQV Engineer - Eli and Lilly Company
CQV Engineer - Eli lilly and CompanyIndianapolis, IN (Onsite)12 Month ContractNo H1B and CPTPossiblity 2nd round On-siteWe 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 ResponsibilitiesExecute Commissioning, Qualification, and Validation (CQV) activities onsitePerform IQ/OQ execution for cGMP equipment and systemsAuthor, route, execute, and approve validation documentation using KNEATConduct equipment and system testing; document results electronically in real timeGenerate test scripts, acceptance criteria, and traceability deliverablesManage deviation documentation and resolution within digital workflowsMaintain inspection ready validation packages in compliance with GMP standardsRequired ExperienceHands on CQV execution experience in GMP manufacturing environmentsStrong working knowledge of KNEAT digital validation platformExperience executing IQ/OQ (PQ exposure a plus)Ability to support documentation heavy validation projectsPreferred (Nice to Have)Site expansion, greenfield, or brownfield project experienceFAT/SAT coordination and startup validation exposureBackground in pharmaceutical, biotech, or CDMO manufacturing environments