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Senior Process Engineer

Salary undisclosed

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Dice
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We are looking for Senior Process Engineer for our client in Fremont, CA
Job Title: Senior Process Engineer
Job Location: Fremont, CA
Job Type: Contract
Job Description:
Pay Range: $51.14hr - $56.14hr
  • The Senior Process Engineer will generally be responsible for processes and operations of medium to high complexity.
  • Evaluate, transfer, and implement new processes into the Fremont GMP facility for the manufacturing of biopharmaceutical drug substances.
  • This includes process transfers of internal 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 support deliverables with GMP/regulatory requirements.
  • Responsible for providing 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 biopharmaceutical 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 experts and liaisons are responsible for the identification and implementation of at-scale manufacturing technology and improvements to effect positive change in 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, and 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.
Skills:
  • Requires the individual to be able to independently plan, execute and deliver with occasional guidance from their leadership.
  • 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 biopharmaceutical 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.
  • To improve the overall efficiency and integrity of routine GMP operations.
  • Regulatory Filing.
  • Project Management.
  • Communication.
  • Engineering.
Physical Requirements (Due to nature of job):
  • Must be able to gown into GMP facility, be able to occasionally stand for a long period.
  • The candidate should be able to lift 50 pounds with assistance.
Education:
  • Bachelor s Degree in Biochemical Engineering (or related field) with 6+ years of professional experience.
  • 10+ years demonstrating equivalent technical/design experience in large-scale biopharmaceutical manufacturing.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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