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Senior Process Engineer
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- Excellent employment opportunity for a Senior Process Engineer, Upstream or Downstream in the Fremont, CA area.
- Responsible to provide direction, strategy, technical leadership, coaching of junior group members, and support for process troubleshooting, process/tech transfers and continuous improvement efforts for a large-scale bio-pharmaceutical manufacturing plant.
- Technical lead for at-scale manufacturing for assigned upstream and/or downstream processes of moderate complexity, inclusive of cell culture medium preparation, cell thaw, inoculum expansion, seed stage bioreactors, production bioreactors, and primary harvest with centrifuge and/or filtration, liquid chromatography, column packing, tangential flow and normal flow filtration, bulk formulation, filling, and freezing.
- Independently or with support from management/Senior SME to author and maintain technical documentation for at-scale processes of higher complexity such as Process Descriptions, Bill of Materials, Campaign Performance Summaries and Presentations, Engineering Run Reports, Engineering Test Protocols, Product/Process Impact Assessments, technical sections of CMC dossiers, BLA Filing, etc.
- Bachelor’s Degree in Biochemical Engineering (or related field) with 6+ years of professional experience or, 10+ years demonstrating equivalent technical/design experience in large scale bio-pharmaceutical manufacturing.
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