Continued Process Verification Engineer
Publication date:
01 October 2024Workload:
100%Contract type:
Permanent position- Place of work:Johnson
Johnson & Johnson is currently seeking a Continued Process Verification Engineer to join our CAR-T team located in Gent, Belgium.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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 CPV engineer is part of the MSAT team and closely connected to the Tech Transfer workstream.
Key responsibilities
- You will be responsible for monitoring the manufacturing process according to Process Validation and Continued Process Verification requirements
- You will be responsible for reviewing the raw data and statistical analyses, analyze out of trends, out of specs and other process parameters
- Write, review and approval of CPV protocols and reports
- You will provide technical leadership by effectively interfacing and collaborating with IT business system owners
- You will pro-actively identify process improvements and optimizations opportunities
- You will strategically prepare for optimizations in the batch documentation process domain
- You will act as a spokesperson for your area during health care inspections
Experience
- It is preferable to have relevant work experience