{"schemaVersion":"jobsearcher.job.v1","id":"e55fcf00e04caff670e5ee00","url":"https://jobsearcher.com/jobs/e55fcf00e04caff670e5ee00","canonicalUrl":"https://jobsearcher.com/jobs/e55fcf00e04caff670e5ee00","title":"Sr. Process Engineer - Containment","description":"Job Requirements Lead and support fill/finish manufacturing operations including vial, syringe, and/or cartridge filling in a GMP-regulated environment\nOwn and execute process validation activities (IQ, OQ, PQ) for filling lines, isolators, and containment systems\nDevelop, review, and approve SOPs, batch records, process descriptions, and technical protocols\nInvestigate manufacturing deviations, OOS results, and equipment failures using structured root cause analysis (CAPA, fishbone, 5-Why)\nProvide technical oversight of isolator and RABS systems, including glovebox integrity testing, decontamination cycles (VHP), and leak testing\nDrive continuous improvement initiatives focused on yield, cycle time, contamination control, and operational efficiency\nCollaborate with Validation, QA, Regulatory Affairs, and Manufacturing teams to support product lifecycle activities and regulatory submissions\nSupport technology transfer of new products into fill/finish operations\nServe as the primary technical resource for filling equipment — providing troubleshooting support and directing engineering changes\nAuthor and review CMC sections and technical reports in support of IND, BLA, and NDA filings as needed\nJob Qualifications Required Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, or a related field\n5+ years of process engineering experience in sterile fill/finish or aseptic manufacturing within a GMP environment\nHands-on experience with containment systems — isolators and/or RABS — including VHP bio-decontamination\nStrong working knowledge of aseptic processing principles, contamination control strategies, and sterility assurance\nExperience authoring and executing validation protocols (IQ/OQ/PQ) and process qualification studies\nSolid understanding of FDA, EU Annex 1, and ICH guidelines relevant to sterile drug product manufacturing\nDemonstrated ability to lead deviation investigations and drive CAPA to closure\nStrong technical writing skills — SOPs, batch records, engineering reports, regulatory documentation\nPreferred Experience with biological drug products (mAbs, vaccines, gene therapy, or other biologics) in fill/finish\nFamiliarity with lyophilization processes and cycle development\nExposure to technology transfer from clinical to commercial scale\nExperience supporting FDA, EMA, or other regulatory agency inspections\nKnowledge of lean manufacturing, Six Sigma, or other process improvement methodologies\nFamiliarity with equipment qualification for automated visual inspection (AVI) systems\nExperience in a CDMO or multi-product manufacturing environment\n\n#J-18808-Ljbffr","company":"Harba","rawCompany":"harba","city":"Carmel","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:15:13.669Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Process Engineer - Containment","description":"Job Requirements Lead and support fill/finish manufacturing operations including vial, syringe, and/or cartridge filling in a GMP-regulated environment\nOwn and execute process validation activities (IQ, OQ, PQ) for filling lines, isolators, and containment systems\nDevelop, review, and approve SOPs, batch records, process descriptions, and technical protocols\nInvestigate manufacturing deviations, OOS results, and equipment failures using structured root cause analysis (CAPA, fishbone, 5-Why)\nProvide technical oversight of isolator and RABS systems, including glovebox integrity testing, decontamination cycles (VHP), and leak testing\nDrive continuous improvement initiatives focused on yield, cycle time, contamination control, and operational efficiency\nCollaborate with Validation, QA, Regulatory Affairs, and Manufacturing teams to support product lifecycle activities and regulatory submissions\nSupport technology transfer of new products into fill/finish operations\nServe as the primary technical resource for filling equipment — providing troubleshooting support and directing engineering changes\nAuthor and review CMC sections and technical reports in support of IND, BLA, and NDA filings as needed\nJob Qualifications Required Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, or a related field\n5+ years of process engineering experience in sterile fill/finish or aseptic manufacturing within a GMP environment\nHands-on experience with containment systems — isolators and/or RABS — including VHP bio-decontamination\nStrong working knowledge of aseptic processing principles, contamination control strategies, and sterility assurance\nExperience authoring and executing validation protocols (IQ/OQ/PQ) and process qualification studies\nSolid understanding of FDA, EU Annex 1, and ICH guidelines relevant to sterile drug product manufacturing\nDemonstrated ability to lead deviation investigations and drive CAPA to closure\nStrong technical writing skills — SOPs, batch records, engineering reports, regulatory documentation\nPreferred Experience with biological drug products (mAbs, vaccines, gene therapy, or other biologics) in fill/finish\nFamiliarity with lyophilization processes and cycle development\nExposure to technology transfer from clinical to commercial scale\nExperience supporting FDA, EMA, or other regulatory agency inspections\nKnowledge of lean manufacturing, Six Sigma, or other process improvement methodologies\nFamiliarity with equipment qualification for automated visual inspection (AVI) systems\nExperience in a CDMO or multi-product manufacturing environment\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T03:15:13.669Z","dateModified":"2026-07-16T03:15:13.669Z","hiringOrganization":{"@type":"Organization","name":"Harba","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Carmel","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e55fcf00e04caff670e5ee00"},"url":"https://jobsearcher.com/jobs/e55fcf00e04caff670e5ee00"}}