Senior Process Engineer
Job Title: Tech Transfer Process Engineer
Location: Eugene, Oregon
Contract duration: 8-12 months
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 CDMOsDraft, 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 CAPAsPartner with Manufacturing, Quality, Analytical, and Regulatory teams
Must-Have:
Skills Excellent technical writer and communicator Experience drafting, reviewing, and executing process development, characterization, and validation protocols for Drug Product operations Experience supporting thaw, formulation, dilution, and vial filling unit operations Tech transfer experience (critical)
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