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RoslinCT · 11 hours ago

Process Engineer

Hopkinton, MA

Full-time

Onsite

Entry, Mid Level

$60K/yr - $95K/yr

2+ years exp

RoslinCT is a leading cell and gene therapy contract development and manufacturing organization. The Process Engineer I/II will develop and execute technology transfer plans, support production, and optimize manufacturing processes while collaborating with various stakeholders to ensure alignment with client program requirements.

BiotechnologyClinical TrialsManufacturing

Hiring Manager

Stacy Adams Coburn

Responsibilities

Partner with colleagues in Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to plan technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable

Support production and QC with process or equipment troubleshooting, deviation management, corrections and CAPA, 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 internal partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports to communicate conclusions

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

Qualification

Aseptic manufacturingCell cultureProcess analyticsBioreactor cell cultureData analysisTechnical writingTroubleshootingOral communicationCross-functional teamwork

Required

B.Sc. in Biological or Chemical Engineering (or similar) with 2-10 years of relevant process and/or analytical experience within the Cell and Gene Therapy or Biologics industry

Hands-on experience with aseptic manufacturing processes, cell culture, and process analytics

Experience with equipment support and troubleshooting

Demonstrated independence in experimental design, execution, data analysis, and troubleshooting