BE - Validation Engineer CAR-T EMEA

Are you thinking about old problems in new ways? Passionate about making an impact? Then you belong at J&J! Johnson & Johnson is working with the latest in technology in order to change the trajectory of human health. Join us and help us improve the health across the world, every day.

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.

Your responsibilities and your Impact:

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

Education and Experience Required for Role

Essential:

• 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

• Problem solving skills and attitude

• Fluent in written and spoken Dutch and English

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

Things to remember before applying for this role:

• We are looking to process the first round of applications within the next 2 working days.

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that we do not accept applications via email).

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Belgium are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.