Process Validation Engineer

Description: Process Validation Engineer Cell Therapy | CAR-T EMEA
Together with our partner Legend Biotech, Johnson & Johnson 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
• 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
  

Qualifications: Experience And Skills

• Experience in the Pharmaceutical, Biotechnology, Cell Therapy, human plasma derived products or related industry is required.
• Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations
• Strong working knowledge of current Good Manufacturing Practices (cGMP)
• Experience working in a controlled, cleanroom environment under aseptic conditions is a plus, but not a must
• Project Management - provide timely and accurate reporting on project activities to peers and leadership
• Ability to interact at different levels of the organization
• Ability to work under pressure, handle conflicting interests, and take decisions
• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
• Team player
• Problem solving skills and attitude
• Fluent in written and spoken dutch and english
  

Education

• A Bachelor’s degree or higher in engineering, biotech, biomedical sciences or pharmacy is required