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Senior Process Engineer, Upstream or Downstream

2 months ago

Fremont, United States eTeam Full time
Job Title: Sr. Process Engineer
Location: Fremont, CA (1st Shift: 8:00AM-5:00PM)
Duration: 12 Months

Shift Timings: 1st Shift: 8:00AM-5:00PM 24/7 operation may occasionally require work outside of 8am-5pm hours.

Duties:
  • The Sr. Process Engineer will generally be responsible for processes and operations of medium to high complexity.
  • Evaluates, transfers, and implements new processes into Client's Fremont GMP facility for the manufacturing of biopharmaceutical drug substance.
  • This includes process transfers of internal client's 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 CClient 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 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.

To improve the overall efficiency and integrity of the routine GMP operations must have skills:
  • Regulatory Filing
  • Project Management
  • Communication
  • Engineering

Must have a strong understanding of fundamental engineering and mathematical concepts pertaining:
  • to cell culture, fluid transfer, gas transfer, and mixing.
  • Possess an excellent mechanical aptitude.
  • Competency with MS Office Programs.
  • Good communication skills.
  • Ability to work in a team setting and as an individual contributor.
  • Flexible to support a 24/7 GMP production facility.
  • Hybrid remote/on-site working environment.

PHYSICAL REQUIREMENTS:
Must be able to gown into GMP facility, be able to occasionally stand for a long period of time and able to lift 50 lbs.

Education:
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.