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Senior Process Engineer, Upstream or Downstream

Fremont, CA 94555

Posted: 08/07/2024 Employment Type: Contract Job Category: Engineering Job Number: 613398 Is job remote?: No Country: United States

Job Description

Duties:
  • Generally responsible for processes and operations of medium to high complexity.
  • Evaluate, transfer, and implement new processes into Boehringer’s Fremont GMP facility for manufacturing biopharmaceutical drug substances.
  • Handle process transfers for internal Boehringer products and external contract manufacturing business (CMB) of client products into the multi-product facility.
  • Implement innovative solutions to complex problems using the best available technology.
  • Provide scientific and technological support during process transfers, launch, and initial supply.
  • Serve as the technical interface between at-scale manufacturing and the customer within a cross-functional project organization, supporting GMP/regulatory requirements.
  • Provide direction, strategy, technical leadership, and coaching for junior group members; support process troubleshooting, tech transfers, and continuous improvement efforts.
  • Act as technical lead for at-scale manufacturing for assigned upstream and/or downstream processes of moderate complexity, including cell culture, bioreactors, primary harvest, liquid chromatography, column packing, filtration, bulk formulation, filling, and freezing.
  • Identify and implement at-scale manufacturing technology and improvements to enhance GMP manufacturing operations.
  • Plan and execute supporting activities as a technical process SME, working with cross-functional teams and external clients to meet project timelines, quality requirements, and identify/mitigate risks.
  • Lead or support evaluating process requirements/facility-fit assessments for medium to high complexity projects, ensuring consistency with standard manufacturing practices, policies, and regulatory requirements.
  • Author and maintain technical documentation for higher complexity at-scale processes, including Process Descriptions, Bill of Materials, Campaign Performance Summaries, Engineering Run Reports, Engineering Test Protocols, Product/Process Impact Assessments, technical sections of CMC dossiers, BLA Filing, etc.
  • Monitor/trend and report for large-scale manufacturing processes, designing and developing data repositories and visualizations to analyze and report process data and trends.
  • Contribute to designing and planning small-scale studies with Process Sciences for transfer to or continuous improvement of at-scale manufacturing.
Skills:
  • Ability to independently plan, execute, and deliver with occasional guidance from 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, benchtop in-process analytics, buffer preparation, and storage for at-scale GMP manufacturing.
  • Experience with technical writing and BLA filing.
  • Skills to improve the overall efficiency and integrity of routine GMP operations:
    • Regulatory Filing
    • Project Management
    • Communication
    • Engineering
  • Strong understanding of fundamental engineering and mathematical concepts related to cell culture, fluid transfer, gas transfer, and mixing.
  • Excellent mechanical aptitude.
  • Competency with MS Office Programs.
  • Good communication skills.
  • Ability to work in a team setting and as an individual contributor.
  • Flexibility to support a 24/7 GMP production facility.
  • Hybrid remote/on-site working environment.
Physical Requirements:
  • Must be able to gown into GMP facility.
  • Ability to occasionally stand for long periods of time.
  • 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 biopharmaceutical manufacturing.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Fremont, CA

Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.