Manufacturing Process Engineer

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.”