Senior Automation Engineer

1 month ago

Fremont, United States System One Holdings, LLC Full time
Job Title: Senior Process Engineer

Location: Fremont, CA

Hours/Schedule: 1st Shift: 8:00AM-5:00PM

Type: Contract

Compensation - $50 - $57.50/hr

Responsibilities
  • Evaluates, transfers, and implements new processes into company's Fremont GMP facility for the manufacturing of biopharmaceutical drug substance.
  • Process transfers of internal company products and external contract manufacturing business (CMB) of client products into the multi-product facility.
  • Demonstrate the expertise and drive to implement innovative solutions to complex problems using the best available technology.
  • Provide scientific and technological support during process transfers, launch, and initial supply.
  • Provide technical interface between at-scale manufacturing and the customer within a cross-functional project organization and supports deliverables with GMP/regulatory requirements.
  • 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.
  • Technical expert and liaison responsible for identification and implementation of at-scale manufacturing technology and improvements to effect positive change to our GMP manufacturing operations.
  • Independently or collaboratively plan and execute supporting activities, serving as an at-scale technical process SME, working with cross-functional teams and external clients to meet project timelines, quality requirements and to identify/mitigate risks.
  • Independently or collaboratively leads evaluating process requirements/facility-fit assessments for medium to high complexity projects including identification of materials/quantities and ensuring that processes are consistent with standard manufacturing practices, policies, and regulatory requirements in the large-scale GMP manufacturing facility.
  • 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.
  • Responsible for periodic process monitoring/trending and reporting for large-scale manufacturing processes inclusive of designing and developing data repositories and visualizations to monitor, analyze, evaluate, and report process data and trends.
  • Contribute to the design and planning of small-scale studies in collaboration with Process Sciences for transfer to or, continuous improvement of, at-scale manufacturing.
Requirements
  • Experience working in cross-functional teams in a dynamic, high-pressure environment.
  • Ability to organize and multi-task in a fast-paced environment.
  • Experience with biopharmaceutical manufacturing processes, Project Management and Technical Writing.
  • Experience with upstream and/or downstream bio-pharmaceutical manufacturing.
  • Knowledge of aseptic processing, and benchtop in-process analytics, buffer preparation and storage for at-scale GMP manufacturing.
  • Experience with technical writing and BLA filing.
  • Must have a strong understanding of fundamental engineering and mathematical concepts pertaining to cell culture, fluid transfer, gas transfer, and mixing.
  • Competency with MS Office Programs.
  • 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.


Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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