Process Engineer II – Cell Therapy Tech Transfer

Energy Jobline ZR; Hopkinton (RI); On-site; USD 85,000 - 120,000; Full time

Job summary

RoslinCT is seeking a Process Engineer I/II to develop and execute technology transfer plans for partner programs. The role collaborates with Manufacturing, Quality, Facilities, and Operations to ensure compliant, efficient processes from development through commercialization.

The candidate will support routine production, troubleshoot issues, and drive continuous improvement in quality and reliability within a dynamic MS&T environment.

Qualifications

• Aseptic manufacturing experience, cell culture and cell therapy instrumentation
• Experience with cell therapy equipment support and troubleshooting
• Independence in experimental design, execution, data analysis and troubleshooting
• Strong communication and collaboration across cross-functional teams
• Proven ability to work in a regulated cGMP environment

Responsibilities

• Support New Product Introduction for products entering RoslinCT facility
• Partner with Operations, Quality Control, Quality Assurance and external partners 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
• Execute feasibility testing of new or alternative technologies and align with program requirements
• Collaborate to determine key process and product monitoring attributes and draft technical reports
• Perform test runs and development studies to support client and RoslinCT initiatives
• Compile data packages and technical documentation for transfer and improvement
• Identify value-adding opportunities across processes and cross-functional teams

Job description

RoslinCT is seeking a Process Engineer I/II to develop and execute technology transfer plans for partner programs. The role collaborates with Manufacturing, Quality, Facilities, and Operations to ensure compliant, efficient processes from development through commercialization.

The candidate will support routine production, troubleshoot issues, and drive continuous improvement in quality and reliability within a dynamic MS&T environment.