Tech Transfer & NPI Engineer — GMP Sterile Manufacturing

United Pharma Technologies Inc

Spokane (WA)

On-site

USD 69,000 - 76,000

Full time

5 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

PTO as per state laws

Job summary

United Pharma Technologies Inc in Spokane, WA is seeking a Tech Transfer Process Engineer to support NPI, technology transfer, equipment implementation, commissioning, qualification, and manufacturing readiness in a GMP-regulated sterile environment.

You will lead and support TT/NPI activities, review transfer packages, CQAs, CPPs, and develop URS and qualification strategies while coordinating with MSAT, Manufacturing, Engineering, Quality, and vendors.

Qualifications

5+ years in pharma, biotech, or sterile manufacturing.
Strong hands-on experience in Technology Transfer / NPI and Process Engineering.
Experience with equipment implementation, commissioning, and qualification.
Knowledge of CQAs, CPPs, Process Validation, and GMP requirements.
Experience developing URS, FAT/SAT, and IQ/OQ protocols.
Strong technical writing and cross-functional coordination skills.

Responsibilities

Lead and support Technology Transfer and New Product Introduction (NPI) activities.
Review sponsor transfer packages, process documentation, CQAs, and CPPs.
Support process development, validation, and manufacturing readiness.
Develop User Requirement Specifications (URS) and equipment qualification strategies.
Coordinate equipment design, procurement, installation, startup, and vendor activities.
Support FAT/SAT, IQ/OQ/PQ, commissioning, and equipment qualification.
Work with process vessels, mixing systems, isolators, CIP/SIP, autoclaves, and aseptic processing equipment.
Manage deviations, CAPAs, change controls, and validation documentation.
Collaborate with MSAT, Manufacturing, Engineering, Quality, Formulation, and equipment vendors.