Process Engineer II - Cell Therapy Tech Transfer Lead

RoslinCT; Hopkinton (MA); On-site; USD 90,000 - 125,000; Full time

Job summary

RoslinCT in Hopkinton, MA seeks a Process Engineer I/II to develop and execute technology transfer plans for partner programs, collaborating with Manufacturing, Quality, and Operations. The role will optimize processes to support products from clinical development to commercialization.

You will draft GMP Batch Records, support GMP production, run feasibility studies, and compile technical reports. A relevant engineering degree with aseptic experience and strong problem-solving is essential.

Qualifications

• Bachelor’s degree with 2-5 years of relevant process/analytical experience in Cell and Gene Therapy.
• Hands-on experience with aseptic manufacturing processes, cell culture, and cell therapy instrumentation.
• Experience with cell therapy equipment support and troubleshooting.
• Demonstrated independence in experimental design, execution, data analysis, and troubleshooting.

Responsibilities

• Support the New Product Introduction for products entering the RoslinCT facility.
• Partner with Operations, Quality Control, and QA, plus external clients and suppliers, to execute technology transfer and validation.
• Draft and design GMP Batch Records and SOPs for partner programs and right-first-time manufacturing.
• Support GMP production with process or equipment troubleshooting, deviation investigations, and CAPAs.
• Execute feasibility testing of new or alternative technologies with stakeholders.
• Collaborate to determine key process and product monitoring attributes and analyze results.
• Perform test runs and development studies to support client and RoslinCT initiatives.
• Compile data packages and technical docs to support technology transfer and process improvement.
• Be proactive in identifying opportunities to add value across cross-functional teams.

Skills

Aseptic manufacturing

Cell culture

Cell therapy instrumentation

Experimental design

Troubleshooting

Education

Bachelor’s degree in Biological, Biomedical or Chemical Engineering

Advanced degree or certifications in science/engineering or cGMP operations

Tools

Microsoft Excel

Statistics software

Job description

RoslinCT in Hopkinton, MA seeks a Process Engineer I/II to develop and execute technology transfer plans for partner programs, collaborating with Manufacturing, Quality, and Operations. The role will optimize processes to support products from clinical development to commercialization.

You will draft GMP Batch Records, support GMP production, run feasibility studies, and compile technical reports. A relevant engineering degree with aseptic experience and strong problem-solving is essential.