Process Validation Engineer (CAR-T)

Location: Ghent, Belgium

Company

hirify.global is an independent technology consulting firm delivering technology, engineering, and life sciences solutions through an international team across more than 60 countries.

What you will do

• Define, plan, and coordinate validation activities for a CAR-T pilot plant, including PPQ, smoke studies, hold time validation, APQ, and APS.
• Provide technical guidance for process validation and equipment qualification.
• Lead the revalidation of manufacturing and sterilization processes.
• Write, review, and approve validation strategies, plans, protocols, reports, and technical documentation.
• Support tech transfer, product introduction, equipment implementation, and system introduction.
• Track risks and deliverables while contributing to process improvement and manufacturing readiness.

Requirements

• 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 another regulated industry.
• Experience introducing pharmaceutical products into manufacturing sites and understanding manufacturing unit operations.
• Strong knowledge of current Good Manufacturing Practices and validation principles.
• Fluent written and spoken Dutch and English required.
• Strong project management, reporting, problem-solving, prioritisation, decision-making, communication, and teamwork skills.

Nice to have

• Experience working in a controlled cleanroom environment under aseptic conditions.

Culture & Benefits

• Permanent position with projects averaging 18 months and involving major accounts.
• Regular project check-ins and monthly HR exchanges.
• Career development, functional mobility, and international mobility across more than 60 countries.
• Access to more than 250 training modules and fully funded Microsoft certifications.
• Health insurance, remote work options, meal vouchers, a time savings account, and a referral bonus.

Hiring process

• Brief virtual or phone call.
• Approximately three interviews, depending on seniority.
• Possible case study, technical assessment, role play, or problem-solving exercise.