Technology Transfer / Equipment Implementation Engineer

United Pharma; Washington; Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

United Pharma seeks an experienced Technology Transfer / Equipment Implementation Engineer to support NPI, technology transfers, equipment implementation, and qualification activities within a sterile pharmaceutical manufacturing environment.

The ideal candidate will own equipment implementation projects from process transfer through design review, procurement, commissioning, qualification, and manufacturing startup, collaborating across Engineering, Manufacturing, MSAT, Quality, Validation, and

Formación

• Bachelor's degree in Engineering or closely related discipline.
• 7+ years of experience in pharmaceutical/biotech/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.

Responsabilidades

• Serve as a technical lead supporting pharmaceutical technology transfer and NPI activities.
• Review and interpret technology transfer documentation from sponsors and development organizations.
• Apply understanding of CPPs and 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 with MSAT, Manufacturing, Quality, Formulation, and Project Management teams.
• Develop and own URS and equipment specifications.
• Lead equipment design reviews and ensure designs meet process and operational requirements.
• Work with vendors through 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 PQ requirements with Manufacturing and Quality teams.
• Drive equipment and process readiness for GMP operations.

Conocimientos

Cross-functional leadership

GMP awareness

Problem solving

Educación

Bachelor's degree in Engineering

Descripción del empleo

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.

Key Responsibilities

• 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.

Quality & Compliance

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

Required Experience

• 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.

Preferred Experience

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