Process Validation Engineer CAR-T
Posted on Thursday, September 7, 2023
CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. Patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.
Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize (CAR) T-cell therapy. This partnership is designed to combine the strengths and expertise of two companies to deliver on the promise of a CAR T platform for immunotherapy and investigational treatment.
To support the CAR-T program in EMEA, we are working with great enthusiasm on expanding our capacity. The Process Validation Engineer is part of the Manufacturing Excellence team and closely connected to the Tech Transfer workstream. You will have the unique opportunity to gain deep knowledge & expertise in a highly innovative and future oriented environment with the ability to profoundly impact the trajectory of health of our patients.
- As process Validation Engineer you will act as a decision maker in the Tech Transfer workstream to support the successful transfer of the CAR-T process, the timely start of clinical and commercial manufacturing and further improvement of the process
- You will immerse yourself in CAR-T processes and build up solid expertise
- You will provide guidance on aspects of validations and qualifications
- You will write, review, and approve validation plans, protocols and reports
- You will act as a spokesperson for your area during health care inspections
- Minimum 5 years of relevant work experience
- You have a Master’s Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …)
- You have a start-up/can-do mindset, and you proactively search for solutions
- You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/guidelines which require strict execution
- You have knowledge of aseptic manufacturing
- You work independently under general direction, having a good sense of prioritization and managing multiple tasks simultaneously
- Your verbal and written communication skills enable you to influence without authority
- You embrace diversity, equity, and inclusion
- The opportunity to participate in a progressive treatment that gives hope to patients in need
- The ability to shape a new venture from the start and work in an innovative working environment
- Opportunities to continue to develop and grow in an extensive and strong organization