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.”