Validation Engineer

Process Validation Engineer Cell Therapy | CAR-T EMEA

Location: Ghent, Belgium

Working mode: On-site (opportunity to work occasionally from home)

Languages: English and ideally Dutch as well

Duration: Starting ASAP through December 31, 2027

Hours: 40 hours per week

Imagine your next project shaping the start-up of a new CAR-T T-cell therapy production process in Europe and working on life-changing blood cancer treatments in Ghent.

roles and responsibilities

• Define strategy, plan, and coordinate validation activities such as PPQ, smoke studies, 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

• 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

• 2–6 years of validation experience in the pharmaceutical industry, including aseptic manufacturing, risk assessments, protocol writing, smoke studies, and PPQ support

• 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

• English proficiency is mandatory; Dutch is fluent in written and spoken or a nice-to-have

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

benefits

This role offers a very competitive hourly rate. This contract will run for starting ASAP through December 31, 2027

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 Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

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 or LinkedIn InMail - you must apply direct to this advert.

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 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”.