We at RoslinCT, are a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY
Here at RoslinCT, our team can contribute 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, as a key member of the MS&T team, will develop and execute technology transfers for partner programs, collaborating with key stakeholders in Manufacturing, Quality, Facilities, and Operations. As a technical subject matter expert and product steward, this role will support technology transfer but also routine production with troubleshooting, technical assessments, investigations and write-ups of deviations, and product disposition evaluations. The Process Engineer will play a key role in optimizing manufacturing processes, ensuring compliance, continuously improving product and process quality, efficiency, and reliability while supporting products, both clinical and commercial.
HOW YOU WILL MAKE AN IMPACT • Partner with colleagues in Manufacturing, Supply Chain, Facilities, Metrology/Validation, Quality Control, and Quality Assurance as well as external
clients and suppliers to execute technology transfer, training runs, engineering runs, and process validation. • 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 management, corrections, and CAPA as needed. • Lead the New Product Introduction for products entering the RoslinCT facility. • Execute feasibility testing of new or alternative technologies and engage with key stakeholders to ensure technology development alignment with company and client program requirements. • Collaborate with partners to establish key processes and product monitoring and control attributes, analyze results, and draft technical reports. • Perform test runs and development studies as needed to support client and company initiatives. • Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement. • Proactively identify opportunities to enhance processes and cross-functional team performance.
WHAT YOU WILL BRING • Bachelor's degree in Biological, Biomedical or Chemical Engineering (or similar) with at least 3 years relevant experience within the Cell Therapy industry. • Hands-on experience with aseptic manufacturing processes, cell culture, and cell therapy instrumentation. • Experience with cell therapy equipment support and troubleshooting. • Proficiency with Quality Systems including but not limited to Deviations, CAPAs, and Change Controls. • Demonstrated independence in experimental execution, data analysis, and troubleshooting. • Will require entry into classified areas with adequate cleanroom PPE and gowning qualification to support routine processing. • May serve in an "on-call" rotation off hours/weekends to respond remotely to urgent processing needs (~1 week per month).
Preferred Qualifications • Advanced degree or additional certifications in science, engineering, or cGMP operations. • Experience in hands-on training curriculum development for cell therapy manufacturing personnel. • Experience supporting both clinical and commercial cell therapy programs. • Proficiency with aseptic cell culture and common cell therapy instrumentation including URS development. • Knowledge of aseptic media fills, process validation and comparability. • Experience performing Risk Assessments (e.g. FMEAs). • Proficiency in Microsoft Word, Excel, PowerPoint and statistical programs for data analysis (JMP or similar) and visualization (Spotfire or similar). • Strong technical writing and oral communication skills. • Self-motivated individual who works well independently and within cross-functional teams.
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.