Process Engineer II

RoslinCT US•Hopkinton, MA

9d•$65,000 - $98,000

About The Position

The Process Engineer II is a member of the MS&T team and develops and executes technology transfer plans for RoslinCT partner programs in collaboration with stakeholders in Manufacturing, Quality, Facilities, and Operations. As a technical subject matter expert, the role supports routine production through troubleshooting, technical assessments of deviations, and product disposition evaluations. The position helps optimize manufacturing processes and ensure compliance while continuously improving quality, efficiency, and reliability, supporting products from clinical development through commercialization. The role also supports new product introduction, equipment setup and qualification, engineering and training runs, process validation, GMP documentation, feasibility testing, process and product monitoring, development studies, and preparation of technical documentation and data packages. The position may participate in an on-call rotation to respond remotely to urgent issues, approximately one week per month.

Requirements

Bachelor’s degree in Biological, Biomedical, or Chemical Engineering, or a similar field.
3–5 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 supporting and troubleshooting cell therapy equipment.
Demonstrated independence in experimental design, execution, data analysis, and troubleshooting.
Excellent technical writing and oral communication skills.
Ability to work independently and within cross-functional teams.

Nice To Haves

Advanced degree or additional certifications in science, engineering, or cGMP operations.
Experience with bioreactor cell culture.
Experience with cell selection, cell washing, lentiviral transduction, and cryopreservation.
Experience with Microsoft Excel and statistical programs for data analysis and visualization.

Responsibilities

Support new product introduction for products entering the RoslinCT facility.
Collaborate with Operations, Quality Control, Quality Assurance, 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 manufacturing execution.
Support GMP production through process or equipment troubleshooting, deviation investigations, and CAPAs as needed.
Conduct feasibility testing of new or alternative technologies and coordinate with stakeholders to align technology development with RoslinCT and client program requirements.
Work with partners to determine process and product monitoring and control attributes experimentally, analyze results, and draft technical reports.
Perform test runs and development studies to support client and RoslinCT initiatives.
Compile data packages, operating procedures, and technical documentation to support technology transfer and process improvement.
Identify opportunities to add value to processes and cross-functional teams.
May participate in an on-call rotation to respond remotely to urgent issues, approximately one week per month.