Process validation engineer

Together with our partner Legend Biotech, Janssen NV will 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.
CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients in whom other therapies have no or insufficient results.
Therefore, we are working with great enthusiasm on expanding our capacity for CAR-T treatments in Europe and are fully developing a new production site in Ghent.
As member of the manufacturing excellence team, you will be part of shaping the start-up of the CAR-T production process in Ghent. The process is transferred from the US to Belgium with primary focus on the implementation of the pilot plant in Ghent. You will be part of tech transfer, validation plan, sterilization validation, equipment introduction and technical writing.

Key Responsibilities:

• Define strategy, plan, and coordinate validation activities such as sterilization, hold time validation, APQ and APS, stability and comparability studies on cell processes.
• Provides guidance on aspects of validations and qualifications
• Assure revalidation of manufacturing and sterilization processes
• Write, review and approval of sterilization-, APS and other related validation plans, protocols and reports
• Participate in product transfer and system introduction teams
• Participate in system and process improvement / optimization projects
• Reviews technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory
  requirements, and current technology
• Support process investigations with accurate knowlegde and competences.