Biotech Process Validation Engineer — GMP, Transfer & Impact

MindCapture BV; Oost-Vlaanderen; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Net expense allowance

Company car

Job summary

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.

Responsibilities

• 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.

Skills

Process validation

Project management

Regulatory compliance

Quality systems

Aseptic operations

Problem solving

Team collaboration

Education

Bachelor's degree in engineering

Job description

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.