Manufacturing Process Engineer
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."