ACCELERATING YOUR FUTURE The
SeniorProcess Engineer,as a key member of the MS&T team, willdevelop and execute technology transfer plans for RoslinCT's partner programs, including collaborating with key stakeholders in Manufacturing, Quality, Facilities, and Operations departments. As a technical subject matter expert, the position will also support routine production with troubleshooting, technical assessments of deviations, and product disposition evaluations. The Process Engineer will play a key role in optimizing manufacturing processes, ensuring compliance, and continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization.
HOW YOU WILL MAKE AN IMPACT - Lead the New Product Introduction for products entering the RoslinCT facility
- Partner with colleagues in Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to execute technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable
- Draft and design GMP Batch Records and SOPs to support partner programs and right-first-time execution by Manufacturing
- Support GMP production with process or equipment troubleshooting, deviation investigations, and CAPAs, as needed
- Execute feasibility testing of new or alternative technologies and engage with key stakeholders to ensure technology development alignment with RoslinCT and client program requirements
- Collaborate with partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports.
- Perform test runs and development studies as needed to support client and RoslinCT initiatives
- Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement
- Be proactive in identifying opportunities to add value to processes and cross-functional teams
WHAT YOU WILL BRING- Bachelor's degree. in Biological, Biomedical or Chemical Engineering (or similar) with 5-10 years of relevant process and/or analytical experience within the Cell and Gene Therapy industry
- Hands-on experience with aseptic manufacturing processes, cell culture, and cell therapy instrumentation
- Experience with cell therapy equipment support and troubleshooting
- Proficiency with Quality Systems including but not limited to Deviations, CAPAs, and Change Controls
- Demonstrated independence in experimental design, execution, data analysis, and troubleshooting
- Excellent technical writing and oral communication skills
- Experience with Microsoft Excel and statistical programs for data analysis and visualization
Preferred Qualifications- Advanced degree or additional certifications in science, engineering, or cGMP operations
- Expertise in bioreactor cell culture
- Expertise in cell selection, cell washing, lentiviral transduction, and cryopreservation
- Knowledge of aseptic media fills, process validation and comparability.
- Experience performing Risk Assessments (e.g. FMEAs).
- Experience supporting both clinical and commercial cell therapy programs.
- Experience in hands-on training curriculum development for cell therapy manufacturing personnel.
- Driven and works well independently and within cross-functional teams
*May serve in an "on call" rotation to respond remotely to urgent issues (~1 week per month)
