{"schemaVersion":"jobsearcher.job.v1","id":"0454a8d92df579c878f6fe2e","url":"https://jobsearcher.com/jobs/0454a8d92df579c878f6fe2e","canonicalUrl":"https://jobsearcher.com/jobs/0454a8d92df579c878f6fe2e","title":"Manufacturing Process Engineer","description":"SummaryWe 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.ResponsibilitiesLead 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 Have5–7 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 HaveDirect 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":"North Chicago","state":"IL","isRemote":false,"isActive":false,"createdAt":"2026-09-06T03:58:18.599Z","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":"SummaryWe 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.ResponsibilitiesLead 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 Have5–7 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 HaveDirect 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":"2026-09-06T03:58:18.599Z","dateModified":"2026-09-06T03:58:18.599Z","hiringOrganization":{"@type":"Organization","name":"Mindlance","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"North Chicago","addressRegion":"IL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"0454a8d92df579c878f6fe2e"},"url":"https://jobsearcher.com/jobs/0454a8d92df579c878f6fe2e"}}