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Senior Process Engineer

2 months ago

Fremont, United States Cynet Systems Full time
Job DescriptionJob Description

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.
Company Descriptionvisit our career site to see all open positions @ http://jobs.cynetsystems.comCompany Descriptionvisit our career site to see all open positions @ http://jobs.cynetsystems.com