Pharma Tech Transfer & Equipment Implementation Lead

United Pharma; Washington; On-site; USD 120,000 - 180,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Cross-functional leadership

GMP awareness

Problem solving

Education

Bachelor's degree in Engineering

Job description

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