{"schemaVersion":"jobsearcher.job.v1","id":"1364f5e5346ba28706c4df91","url":"https://jobsearcher.com/jobs/1364f5e5346ba28706c4df91","canonicalUrl":"https://jobsearcher.com/jobs/1364f5e5346ba28706c4df91","title":"Manufacturing Process Engineer","description":"Summary We are seeking a Process Support Engineer III to provide technical leadership for the technology transfer of a sterile ophthalmic drug product to a new manufacturing site. The role will support a third-party manufacturing partner and work cross-functionally across Manufacturing, Quality, Validation, Regulatory, and Engineering. The ideal candidate has strong sterile/aseptic manufacturing, GMP, process validation, and technical project leadership experience. Responsibilities Lead technical activities supporting sterile product technology transfer to a new manufacturing site. Support validation strategy, protocol review, data evaluation, and GMP documentation. Conduct process gap assessments and identify technical risks and transfer requirements. Partner with third-party manufacturers and cross-functional teams to resolve technical issues. Track technical deliverables, timelines, risks, and action items. Support process improvements and risk-mitigation activities where appropriate. Must Have 5–7 years of relevant pharmaceutical, biotech, or regulated medical-device experience. Strong experience in sterile/aseptic manufacturing and GMP environments. Experience with process validation and technical/regulatory documentation. Strong understanding of manufacturing processes, troubleshooting, and risk assessment. Demonstrated ability to provide technical leadership and coordinate cross-functional teams. Bachelor’s, Master’s, or Ph.D. in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline. Nice to Have Direct technology transfer experience, particularly site-to-site or CMO transfers. Experience with sterile ophthalmic products. Experience with gap assessments, validation protocols, and validation data evaluation. Experience working with third-party/contract manufacturing organizations (CMOs). Strong technical project-management skills, including timeline and action-item tracking. Experience identifying and implementing process improvements. EEO:“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”","company":"Mindlance","rawCompany":"mindlance","city":"Chicago","state":"IL","isRemote":false,"isActive":false,"createdAt":"2026-09-08T08:14:03.030Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.00","title":"Industrial Production Managers","slug":"industrial-production-managers"}],"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":"339115","title":"Ophthalmic Goods Manufacturing","slug":"ophthalmic-goods-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manufacturing Process Engineer","description":"Summary We are seeking a Process Support Engineer III to provide technical leadership for the technology transfer of a sterile ophthalmic drug product to a new manufacturing site. The role will support a third-party manufacturing partner and work cross-functionally across Manufacturing, Quality, Validation, Regulatory, and Engineering. The ideal candidate has strong sterile/aseptic manufacturing, GMP, process validation, and technical project leadership experience. Responsibilities Lead technical activities supporting sterile product technology transfer to a new manufacturing site. Support validation strategy, protocol review, data evaluation, and GMP documentation. Conduct process gap assessments and identify technical risks and transfer requirements. Partner with third-party manufacturers and cross-functional teams to resolve technical issues. Track technical deliverables, timelines, risks, and action items. Support process improvements and risk-mitigation activities where appropriate. Must Have 5–7 years of relevant pharmaceutical, biotech, or regulated medical-device experience. Strong experience in sterile/aseptic manufacturing and GMP environments. Experience with process validation and technical/regulatory documentation. Strong understanding of manufacturing processes, troubleshooting, and risk assessment. Demonstrated ability to provide technical leadership and coordinate cross-functional teams. Bachelor’s, Master’s, or Ph.D. in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline. Nice to Have Direct technology transfer experience, particularly site-to-site or CMO transfers. Experience with sterile ophthalmic products. Experience with gap assessments, validation protocols, and validation data evaluation. Experience working with third-party/contract manufacturing organizations (CMOs). Strong technical project-management skills, including timeline and action-item tracking. Experience identifying and implementing process improvements. EEO:“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”","datePosted":"2026-09-08T08:14:03.030Z","dateModified":"2026-09-08T08:14:03.030Z","hiringOrganization":{"@type":"Organization","name":"Mindlance","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Chicago","addressRegion":"IL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"1364f5e5346ba28706c4df91"},"url":"https://jobsearcher.com/jobs/1364f5e5346ba28706c4df91"}}