Tech Transfer Process Engineer Oregon
Job in
Eugene, Lane County, Oregon, 97401, USA
Listed on 2026-10-25
Listing for:
Fusion Life Sciences
Full Time
position Listed on 2026-10-25
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering -
Pharmaceutical
Validation Engineer, Pharma Engineer, Pharmaceutical Manufacturing, Quality Engineering
Job Description & How to Apply Below
Job Description
Job Description
Tech Transfer Process Engineer
Summary: Support the transfer, scale-up, and commercialization of drug product processes into GMP manufacturing, with a focus on thaw, formulation, dilution, and vial filling operations.
Responsibilities
- Lead and support tech transfer processes between development, clinical, and commercial sites or CDMOs
- Draft, review, and execute process development, characterization, and validation protocols and reports
- Provide on-the-floor support for thaw, formulation, dilution, and vial filling during engineering and GMP runs
- Author tech transfer plans, batch records, risk assessments, and summary reports
- Support deviations, root cause analysis, and CAPAs
- Partner with Manufacturing, Quality, Analytical, and Regulatory teams
Must-Have Skills
Qualifications
- Bachelor's in Chemical Engineering, Biotechnology, or a related field
- 3-7 years in Drug Product manufacturing, process development, or tech transfer
- Working knowledge of cGMP and process validation principles
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