Technology Transfer​/Equipment Implementation Engineer

We are seeking an experienced Technology Transfer / Equipment Implementation Engineer to support new product introductions (NPI), technology transfers, equipment implementation, and qualification activities within a sterile pharmaceutical manufacturing environment.

This is not a traditional CQV role. The ideal candidate will have a strong engineering background and experience owning equipment implementation projects from process transfer through design review, procurement, commissioning, qualification, and manufacturing startup.

The successful candidate will serve as a key technical resource working across Engineering, Manufacturing, MSAT, Quality, Validation, and external vendors to ensure successful transfer and commercialization of new products.

• Serve as a technical lead supporting pharmaceutical technology transfer and new product introduction activities.
• Review and interpret technology transfer documentation from sponsors and development organizations.
• Apply understanding of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to manufacturing implementation activities.
• Translate process and formulation requirements into manufacturing and equipment requirements.
• Support manufacturing readiness, process implementation, engineering runs, PPQ activities, and commercial startup efforts.
• Collaborate closely with MSAT, Manufacturing, Quality, Formulation, and Project Management teams.
• Develop and own User Requirement Specifications (URS).
• Develop equipment specifications and technical requirements.
• Lead equipment design reviews and ensure designs meet process and operational requirements.
• Work directly with vendors throughout equipment selection, procurement, fabrication, delivery, installation, and startup.
• Manage technical aspects of equipment implementation projects from concept through operational handoff.
• Support equipment troubleshooting and startup activities.
• Own and coordinate FAT and SAT activities.
• Develop and execute IQ/OQ protocols.
• Coordinate Performance Qualification (PQ) requirements with Manufacturing and Quality teams.
• Support qualification strategy development and validation planning.
• Drive equipment and process readiness for GMP operations.

• Manage deviations, CAPAs, and change controls.
• Work within Track Wise or similar quality systems.
• Support investigations, root cause analysis, and implementation of corrective actions.
• Ensure activities comply with GMP regulations and site quality standards.

• Bachelor's degree in Engineering or closely related technical discipline.
• 7+ years of experience within pharmaceutical, biotech, biologics, or sterile manufacturing environments.
• Direct experience supporting technology transfer and/or new product introduction projects.
• Experience interpreting and implementing CPPs and CQAs.
• Strong understanding of process development, process validation, and manufacturing scale-up activities.
• Experience developing equipment specifications and URSs.
• Experience participating in or leading design reviews.
• Experience working directly with equipment vendors.
• Experience with FAT, SAT, IQ, OQ, and PQ activities.
• Experience with deviations, CAPAs, and change controls.
• Strong communication and cross-functional leadership skills.

• Sterile manufacturing environments.
• Process vessels and mixing systems.
• MSAT (Manufacturing Science & Technology).