{"schemaVersion":"jobsearcher.job.v1","id":"c4f82fc0e0b045580dc1f086","url":"https://jobsearcher.com/jobs/c4f82fc0e0b045580dc1f086","canonicalUrl":"https://jobsearcher.com/jobs/c4f82fc0e0b045580dc1f086","title":"Commissioning Qualification Engineer","description":"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.\n\nWe 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.\n\nThis 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.\n\nProject Scope:\n\nSterile filling lines\n\nLyophilizers (freeze dryers)\n\nVial washing and sterilization systems\n\nIsolators and aseptic processing equipment\n\nClean utilities (WFI, clean steam, process gases)\n\nHVAC and environmental control systems\n\nPackaging and supporting production equipment\n\nResponsibilities:\n\nSupport commissioning and qualification activities for new sterile manufacturing equipment and utilities\n\nDevelop and execute commissioning test plans and IQ/OQ protocols\n\nCoordinate testing with engineering, automation, quality, and operations teams\n\nAssist with equipment installation verification and turnover from construction to operations\n\nTroubleshoot issues identified during commissioning or qualification\n\nReview vendor documentation, design packages, and P&IDs\n\nSupport documentation packages required for GMP compliance and regulatory readiness\n\nParticipate in punch‑list resolution and system startup activities\n\nQualifications:\n\nBachelor’s degree in Engineering or related technical discipline\n\n2-5 years of experience in commissioning, qualification, or validation\n\nExperience working in GMP regulated manufacturing environments\n\nExperience with sterile manufacturing or aseptic processing preferred\n\nFamiliarity with qualification of:\n\nsterile fill‑finish systems\n\nlyophilizers\n\nclean utilities (WFI, clean steam, HVAC)\n\nAbility to read engineering drawings, P&IDs, and system design documentation\n\nStrong communication skills and ability to work within multi-disciplinary project teams\n\n#J-18808-Ljbffr","company":"Technical Source","rawCompany":"technical source","city":"Lexington","state":"KY","isRemote":false,"isActive":false,"createdAt":"2026-07-16T04:03:36.024Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"238290","title":"Other Building Equipment Contractors","slug":"other-building-equipment-contractors"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Commissioning Qualification Engineer","description":"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.\n\nWe 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.\n\nThis 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.\n\nProject Scope:\n\nSterile filling lines\n\nLyophilizers (freeze dryers)\n\nVial washing and sterilization systems\n\nIsolators and aseptic processing equipment\n\nClean utilities (WFI, clean steam, process gases)\n\nHVAC and environmental control systems\n\nPackaging and supporting production equipment\n\nResponsibilities:\n\nSupport commissioning and qualification activities for new sterile manufacturing equipment and utilities\n\nDevelop and execute commissioning test plans and IQ/OQ protocols\n\nCoordinate testing with engineering, automation, quality, and operations teams\n\nAssist with equipment installation verification and turnover from construction to operations\n\nTroubleshoot issues identified during commissioning or qualification\n\nReview vendor documentation, design packages, and P&IDs\n\nSupport documentation packages required for GMP compliance and regulatory readiness\n\nParticipate in punch‑list resolution and system startup activities\n\nQualifications:\n\nBachelor’s degree in Engineering or related technical discipline\n\n2-5 years of experience in commissioning, qualification, or validation\n\nExperience working in GMP regulated manufacturing environments\n\nExperience with sterile manufacturing or aseptic processing preferred\n\nFamiliarity with qualification of:\n\nsterile fill‑finish systems\n\nlyophilizers\n\nclean utilities (WFI, clean steam, HVAC)\n\nAbility to read engineering drawings, P&IDs, and system design documentation\n\nStrong communication skills and ability to work within multi-disciplinary project teams\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T04:03:36.024Z","dateModified":"2026-07-16T04:03:36.024Z","hiringOrganization":{"@type":"Organization","name":"Technical Source","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Lexington","addressRegion":"KY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"c4f82fc0e0b045580dc1f086"},"url":"https://jobsearcher.com/jobs/c4f82fc0e0b045580dc1f086"}}