Senior Process Engineer
4 weeks ago
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.
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