Sr. Process Engineer
This role will develop and execute technology transfer plans for client processes, including working with key stakeholders in Manufacturing, Quality, Technology, and Operations departments. As a technical subject matter expert, the position will support routine production with troubleshooting, technical assessments of deviations, and product disposition evaluations. The position will play a key role in optimizing manufacturing processes and test methods, continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization.
Duties and responsibilities
- Partner with colleagues in Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to plan technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable.
- Support production and QC with process or equipment troubleshooting, deviation management, corrections and CAPA, as needed
- Collaborate with internal partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports to communicate conclusions
- Perform test runs and development studies as needed to support client and initiatives
- Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement
- B.Sc. in Biological or Chemical Engineering with 6-10 years of relevant process and/or analytical experience within the Cell and Gene Therapy or Biologics industry
- Hands-on experience with aseptic manufacturing processes, cell culture, and process analytics
- Demonstrated independence in experimental design, execution, data analysis, and troubleshooting
- Advanced degree or additional certifications in science, engineering, or cGMP operations
- Experience with bioreactor cell culture, viral vector production, cryopreservation
- Experience with cell selection, cell washing, lentiviral transduction, and cryopreservation
- Experience with Microsoft Excel and statistical programs for data analysis (JMP) and visualization
- Excellent technical writing and oral communication skills
Sthree US is acting as an Employment Business in relation to this vacancy.