Process Validation Engineer

MindCapture BV; Oost-Vlaanderen; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Résumé du poste

MindCapture BV is seeking a Process Validation Engineer to shape the future of advanced cell therapy manufacturing. You will validate and support complex processes, coordinate PPQ, APQ, and hold time studies while ensuring GMP compliance in regulated environments.

You’ll lead validation plans, programs and reports, support technology transfer, and drive process improvements. Fluency in Dutch and English is required; a strong project mindset is essential for success in this role.

Qualifications

• Bachelor degree or higher in engineering, biotechnology, biomedical sciences or pharmacy.
• Experience within pharmaceutical, biotechnology, cell therapy or a related regulated industry.
• Experience introducing pharmaceutical products into manufacturing environments.
• Strong working knowledge of GMP and aseptic/cleanroom environments preferred.
• Fluent written and spoken Dutch and English.

Responsabilités

• Define strategies, plan and coordinate process validation activities including PPQ, smoke studies, hold time validation, APQ and APS.
• Provide technical guidance on validation and qualification activities.
• Ensure revalidation of manufacturing and sterilisation processes.
• Write, review and approve validation plans, protocols and reports.
• Support technology transfer and manufacturing system introduction.
• Contribute to process improvement and optimisation projects.
• Review technical documentation to ensure alignment with regulatory requirements and current industry standards.

Connaissances

Process validation

Project management

Regulatory compliance

Quality systems

Aseptic operations

Problem solving

Team collaboration

Formation

Bachelor's degree in engineering

Description du poste

Shape the future of advanced cell therapy manufacturing as a Process Validation Engineer. You will support the implementation and validation of complex manufacturing processes, combining technical expertise with hands on project involvement.

What's offered?

Ready to grow your career and make real impact? Join MindCapture!

We offer competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance, and a company car). You also get the opportunity to shape your future through personalised training and development.

At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most.

You will work as a MindCapture consultant for an international market leader in the biotechnology industry.

Job Description:

• Define strategies, plan and coordinate process validation activities including PPQ, smoke studies, hold time validation, APQ and APS
• Provide technical guidance on validation and qualification activities
• Ensure revalidation of manufacturing and sterilisation processes
• Write, review and approve validation plans, protocols and reports
• Support technology transfer and manufacturing system introduction
• Contribute to process improvement and optimisation projects
• Review technical documentation to ensure alignment with regulatory requirements and current industry standards

Requirements:

• Bachelor degree or higher in engineering, biotechnology, biomedical sciences or pharmacy
• Experience within pharmaceutical, biotechnology, cell therapy or a related regulated industry
• Experience introducing pharmaceutical products into manufacturing environments
• Strong technical understanding of manufacturing operations
• Strong working knowledge of current Good Manufacturing Practices
• Experience working under aseptic conditions within controlled cleanroom environments is preferred
• Strong project management and reporting capabilities
• Ability to prioritise tasks, work independently and make decisions under pressure
• Strong problem solving skills and collaborative mindset
• Fluent written and spoken Dutch and English

Are you ready to make a real difference in healthcare?

Join our dynamic team and help drive innovation in biotechnology.

If MindCapture sees a potential fit, we’ll get in touch as soon as possible.

If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep your profile in mind for future roles that could suit you better.