Process Validation Engineer

Process Validation Engineer

• Location: Ghent, East Flanders, Belgium

• Duration: 31 December 2026

• Hours: 40

Imagine your next project shaping the start-up of a state-of-the-art CAR-T production site to deliver life-saving cancer treatments.

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.

roles and responsibilities.

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.

This will involve:

• 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

how to succeed.

To be successful in this role, you will need to demonstrate strong working knowledge of current Good Manufacturing Practices (cGMP) and experience in the Pharmaceutical, Biotechnology, or Cell Therapy industries.

You will also bring:

• A Bachelor’s degree or higher in engineering, biotech, biomedical sciences or pharmacy (Required)

• Experience in the Pharmaceutical, Biotechnology, Cell Therapy, human plasma derived products or related industry (Required)

• Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations

• Project Management skills to provide timely and accurate reporting on project activities

• 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

• Team player mindset with problem solving skills

• Fluency in written and spoken Dutch and English

benefits.

This role offers a very competitive hourly rate. This contract will run until 31 December 2026.

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying our rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

application process.

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

We do not accept applications via email.

Diversity, Equity & Inclusion.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.