Commissioning Qualification Engineer

Technical Source is currently supporting a major sterile manufacturing expansion in a Lexington, KY facility. This project is being led by our partner and involves the installation and startup of new aseptic manufacturing and lyophilization systems as part of a large-scale sterile fill‑finish expansion.We are seeking Commissioning & Qualification Engineers to support the startup, testing, and qualification of new GMP manufacturing systems and utilities as the project progresses toward operational readiness.This role will work closely with partner engineering teams, client‑owner operations, and quality groups to ensure systems are commissioned and qualified in accordance with regulatory requirements and project schedules.Project Scope:Sterile filling linesLyophilizers (freeze dryers)Vial washing and sterilization systemsIsolators and aseptic processing equipmentClean utilities (WFI, clean steam, process gases)HVAC and environmental control systemsPackaging and supporting production equipmentResponsibilities:Support commissioning and qualification activities for new sterile manufacturing equipment and utilitiesDevelop and execute commissioning test plans and IQ/OQ protocolsCoordinate testing with engineering, automation, quality, and operations teamsAssist with equipment installation verification and turnover from construction to operationsTroubleshoot issues identified during commissioning or qualificationReview vendor documentation, design packages, and P&IDsSupport documentation packages required for GMP compliance and regulatory readinessParticipate in punch‑list resolution and system startup activitiesQualifications:Bachelor's degree in Engineering or related technical discipline2-5 years of experience in commissioning, qualification, or validationExperience working in GMP regulated manufacturing environmentsExperience with sterile manufacturing or aseptic processing preferredFamiliarity with qualification of:sterile fill‑finish systemslyophilizersclean utilities (WFI, clean steam, HVAC)Ability to read engineering drawings, P&IDs, and system design documentationStrong communication skills and ability to work within multi-disciplinary project teams#J-18808-Ljbffr