Cell Therapy Process Engineer II: Tech Transfer & GMP

RoslinCT US; Hopkinton (MA); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

RoslinCT US is seeking a Process Engineer II to develop and execute technology transfer plans for partner programs. You will collaborate with Manufacturing, Quality, Facilities and Operations to optimize processes and ensure compliance as products move from clinical development to commercialization.

You bring hands-on experience with aseptic manufacturing, cell culture, and cell therapy instrumentation, plus independence in experimental design, data analysis, and troubleshooting.

Qualifikationen

• Bachelor’s degree in Biological, Biomedical or Chemical Engineering with 3–5 years of relevant process and/or analytical experience in cell 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.

Aufgaben

• Support New Product Introduction for products entering the RoslinCT facility.
• Collaborate with 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.

Kenntnisse

Aseptic manufacturing

Cell culture

Experimental design

Data analysis

Troubleshooting

Process transfer

Documentation

Cross-functional collaboration

Quality systems

Ausbildung

Bachelor's degree in Biological, Biomedical or Chemical Engineering

Tools

Microsoft Excel

Statistical software

Jobbeschreibung

RoslinCT US is seeking a Process Engineer II to develop and execute technology transfer plans for partner programs. You will collaborate with Manufacturing, Quality, Facilities and Operations to optimize processes and ensure compliance as products move from clinical development to commercialization.

You bring hands-on experience with aseptic manufacturing, cell culture, and cell therapy instrumentation, plus independence in experimental design, data analysis, and troubleshooting.