Job Information
J&J Family of Companies Continued Process Verification Engineer in East Flanders, Belgium
Continued Process Verification Engineer - 2406173747W
Description
Continuous Process Verification Engineer | CAR-T EMEA
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 Manufacturing Excellence 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
Qualifications
Experience
- It is preferable to have relevant work experience
Skills
You have a Bachelor or 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 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
Our offer
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
Primary Location Europe/Middle East/Africa-Belgium-East Flanders-Ghent
Organization Janssen Pharmaceutica N.V. (7555)
Job Function Process Engineering
Req ID: 2406173747W