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Upstream Support Engineer
Ref No.: 20-02387
Location: Vacaville, California
Considered the founder of the industry, our client has been delivering on the promise of biotechnology for over 40 years. Our client is considered the leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

Duties:
SPECIFIC FUNCTIONAL AND AUTOMATION TASKS
● Develop pin charts associated with equipment phases/procedures, set-ups/break-downs
● Develop and update functional specification
● Configure recipes for upstream equipment in CCP2
● Perform Cleaning Comparability Assessment (CIP related):
○ Write technical paper for existing cleaning recipes, outlining critical clean parameters (T-time, A-action, C-concentration, T-temperature) for each equipment's cleaning cycle
○ Trace above parameters to the new automation system cleaning cycle parameters
○ Author technical paper outlining the acceptability of the previous cleaning validation to the new cleaning cycle
● Perform offline functional testing of recipes to ensure functionality is delivered
● Perform field testing of cleaning cycles (CIP related)
● Perform Sterilization Comparability Assessment:
○ Write technical paper for existing sterilization recipes, outlining critical parameters (Steam exposure time, Temperature, sterile boundary assessment) for each equipment's sterilization cycle
○ Trace above parameters to the new automation system sterilization cycle parameters
○ Author technical paper outlining the acceptability of the previous sterilization validation to the new sterilization cycle
● Perform offline functional testing of sterilization recipes to ensure functional cycles are delivered
● Perform field testing of sterilization cycles

Skills:
Experience
● 8-12 years of design and/or operational experience related to Large Scale Biopharmaceutical Upstream processing with particular emphasis on CIP systems and SIP
Knowledge/Skills/Competencies
● Demonstrates competence in understanding quantitative and qualitative process engineering principles and concepts with an ability to provide solutions to complex technical problems in the bio-pharmaceutical processing.
● Operational competence of Upstream systems related manufacturing steps, and good understanding of complete Mammalian Cell Culture Upstream Process.
● Strong knowledge of the Automation architecture and hardware / software requirement development
● Cross-knowledge of Cell Culture Process Downstream and Process Supports (e.g. CIP/SIP, Parts Washers/Autoclaves) is desirable.
● Good understanding of the applicable codes and guidelines (e.g. ASME / ASME-BPE )
● Capable of providing creative, out of the box approaches to design and operating challenges.
● Good understanding of Project Management concepts and execution phases / deliverables for each phase.
● Working knowledge of applicable Quality Systems (e.g. Clean Utilities, sampling /QC).
● Working knowledge of cGMP practices, experience of working in a cGMP environment.
● Excellent written, verbal, and presentation skills with proven ability to use market available software.

Education:
● Bachelor Degree in Chemical or Bio-Chemical Engineering is preferred. Degrees in Mechanical and Nuclear Engineering or equivalent operating experience coupled with Bachelor of Science in relevant scientific disciplines is considered.