Tech Transfer Process Engineer
Job in
Bellingham, Whatcom County, Washington, 98227, USA
Listed on 2026-09-23
Listing for:
United Pharma
Full Time
position Listed on 2026-09-23
Job specializations:
-
Manufacturing / Production
Validation Engineer, Pharmaceutical Manufacturing, Quality Engineering -
Engineering
Validation Engineer, Quality Engineering, Pharma Engineer
Job Description & How to Apply Below
The Process Engineer will support the transfer of new products into a CDMO manufacturing site, working closely with clients and cross-functional teams to ensure successful process transfer, development, and validation.
This is a hands-on manufacturing-floor role focused primarily on incoming NPI technical transfers, process development, risk assessment, batch execution, and technical documentation.
Key Responsibilities:- Lead and support NPI technical transfer activities for sterile/aseptic fill-finish products.
- Collaborate directly with clients to gather and evaluate product, process, and technical data
. - Develop and author Technical Transfer Plans, Process Control Strategies, and transfer documentation
. - Coordinate activities required to develop, establish, and validate processes at the manufacturing site.
- Perform process risk assessments and identify potential manufacturing risks and mitigation strategies.
- Develop and execute hands-on batch sampling and process study protocols
. - Provide on-floor engineering support during manufacturing runs, process trials, and technical transfer activities
. - Support change controls, deviations, investigations, and corrective actions associated with transferred products.
- Ensure activities are completed in accordance with GMP, site procedures, and applicable pharmaceutical regulations
.
Skills & Experience:
- 8-10+ years of pharmaceutical industry experience
. - Strong CDMO experience in a fast-paced manufacturing environment.
- Hands-on experience with sterile/aseptic fill-finish manufacturing
. - Experience working directly on or supporting commercial/manufacturing lines
. - Proven experience with NPI and technical transfer activities
. - Strong understanding of process development, process validation, and manufacturing readiness
. - Experience with risk assessments, protocols, change controls, deviations, and technical reports
. - Comfortable working directly with clients and cross-functional teams.
- Must be hand-on and willing to work on the manufacturing floor
.
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