Process Engineer II presso RoslinCT

WHO WE ARE 

We are a leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Join a company where collaborative, dedicated, and talented people are the backbone of our culture. Work both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY 

Here at RoslinCT, our team contributes to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE 

The Process Engineer I/II will develop and execute technology transfer plans for RoslinCT’s client processes, including working with key stakeholders in Manufacturing, Quality, Technology, and Operations departments. As a technical subject matter expert, the position will support routine production with troubleshooting, technical assessments of deviations, and product disposition evaluations. The position will play a key role in optimizing manufacturing processes and test methods, continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization. 

 HOW YOU WILL MAKE AN IMPACT      

• 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 

WHAT YOU WILL BRING

• 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 

 Preferred Qualifications

• 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 
• Excellent technical writing and oral communication skills 
• Driven and works well independently and within cross-functional teams 

*May serve in an “on call” rotation to respond remotely to urgent issues (~1 week per month)  

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.