Process Validation Engineer CAR-T

Job Description
As a Process Validation Engineer, Cell Therapy, you’ll join the Manufacturing Excellence team supporting the start-up of a new CAR-T production site in Ghent. You’ll contribute to the implementation of the pilot plant and the launch of the CAR-T manufacturing process, with a focus on tech transfer, process and sterilization validation, equipment introduction, and technical documentation. Working with cross-functional teams, you’ll help ensure that manufacturing activities are ready for compliant and reliable production. Your missions
• Define, plan, and coordinate validation activities for the CAR-T pilot plant in Ghent, including PPQ, smoke studies, hold time validation, APQ, and APS.
• Provide technical guidance on process validation and equipment qualification activities.
• Lead the revalidation of manufacturing and sterilization processes.
• Write, review, and approve validation strategies, plans, protocols, reports, and related technical documentation.
• Support tech transfer, product introduction, equipment implementation, and system introduction activities.
• Review technical reports and procedures to ensure compliance with cGMP, regulatory requirements, and current industry practices.
• Contribute to process improvement projects, while tracking activities, risks, and deliverables with project teams and leadership.

Your profile
• Bachelor’s degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or a related field.
• Experience in pharmaceutical, biotechnology, cell therapy, human plasma-derived products, or a comparable regulated industry.
• Experience introducing pharmaceutical products into manufacturing sites, with a good understanding of manufacturing unit operations.
• Strong knowledge of current Good Manufacturing Practices and validation principles.
• Experience working in a controlled cleanroom environment under aseptic conditions is a plus.
• Strong project management, reporting, problem-solving, prioritisation, and decision-making skills.
• Ability to work independently and as part of a team, communicate with stakeholders at different levels, and work fluently in written and spoken Dutch and English.

What we offer
Joining Amaris means working in an environment where your performance supports your career progression. Projects with substance Our projects last 18 months on average and involve major accounts such as Orange, Sanofi, SNCF, and CMA-CGM. You’ll work on assignments where your experience has a direct impact on project delivery and product quality. Support from your manager and HR Each manager supports up to 18 consultants. You’ll have regular project check-ins and a direct exchange with HR every month through Express Yourself. Our teams have an average tenure of 3.3 years. Career progression 70% of our managers started in entry-level positions. Career development is based on skills, performance, and the opportunities you take. Functional mobility across 4 areas of expertise and international mobility across 60+ countries are actively encouraged. Learning and technology You’ll have access to 250+ training modules, fully funded Microsoft certifications, and 291 AI agents developed in-house. We support continuous learning throughout your career. Social and environmental commitments Our commitments include an SBTi carbon reduction roadmap, a target of 34.3% women in management by 2029, and social engagement through We Care Together. Health insurance, remote work, meal vouchers, a time savings account, and a referral bonus are also available. We’ll discuss the full benefits package during the recruitment process. Amaris Consulting is proud to be an equal-opportunity workplace. We’re committed to building a diverse and inclusive working environment. We welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic. Who are we? Amaris Consulting, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like: Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you Interviews (the average number of interviews is 3
- the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc. As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. We look forward to meeting you