Commissioning & Qualification (C&Q) Engineer

We are seeking an experienced Commissioning & Qualification (C&Q) Engineer to support a major capital expansion project involving the installation of multiple new packaging lines within a pharmaceutical manufacturing environment. This is a hands-on role focused on commissioning, equipment qualification, system turnover, and manufacturing process support for secondary and tertiary packaging operations of final drug products.The ideal candidate will have strong expertise in equipment commissioning, on-floor manufacturing operations, and GMP-regulated pharmaceutical environments. Prior packaging line experience is preferred.Key ResponsibilitiesLead and execute commissioning and qualification activities for new secondary and tertiary packaging equipment installationsDevelop, author, review, and execute C&Q documentation including commissioning plans, protocols, test scripts, punch lists, and turnover packagesPerform hands-on equipment walkdowns, commissioning checks, and system verifications directly on the manufacturing floorManage punch list identification, tracking, resolution, and final system turnover activitiesSupport Site Acceptance Testing (SAT) activities for incoming packaging equipmentCollaborate with engineering, construction, operations, quality, and vendor teams to ensure successful equipment installation and commissioningVerify systems are installed and functioning according to design specifications and operational requirementsEnsure all C&Q activities comply with FDA, GMP, and site regulatory standardsApply manufacturing process knowledge to support operational readiness and successful GMP handoverMaintain accurate commissioning and qualification records in accordance with site documentation and data integrity requirementsSupport clean and compliant turnover of systems into manufacturing operationsRequired QualificationsBachelor’s degree in Engineering or related technical discipline6+ years of experience in Commissioning & Qualification (C&Q) within pharmaceutical, biotech, or regulated manufacturing environmentsStrong hands-on experience with equipment commissioning, qualification, and system turnover activitiesExperience working within GMP/FDA-regulated manufacturing facilitiesKnowledge of secondary and tertiary packaging systems preferredStrong understanding of manufacturing floor operations and packaging processesExperience managing punch lists, walkdowns, SAT, and turnover documentationAbility to work cross-functionally with engineering, operations, quality, and vendorsExcellent documentation, communication, and problem-solving skillsPreferred QualificationsPrior experience supporting capital expansion or packaging line installation projectsExperience within pharmaceutical packaging operationsStrong knowledge of commissioning lifecycle and turnover processesAbility to work in a fast-paced manufacturing environment with multiple concurrent projects