Process Validation Engineer - Cell Therapy | Growth & Impact

MindCapture BV; Belgique; Sur place; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Company car with charging or fuel card

On-site training

Résumé du poste

MindCapture BV is seeking a Process Validation Engineer for Cell Therapy to coordinate validation activities in a new manufacturing environment. You will oversee validation strategy, approvals, and documentation while ensuring GMP compliance and regulatory alignment.

Ideal candidates hold a technical degree and have experience in regulated pharma/biotech settings, including sterile environments and technology transfer.

Qualifications

• Bachelor degree or higher in engineering, biotechnology, biomedical sciences or pharmacy.
• Experience within pharmaceutical, biotechnology, cell therapy or related regulated industry.
• Manufacturing knowledge: experience introducing pharmaceutical products into manufacturing environments.
• Technical expertise: working knowledge of manufacturing operations and late-stage development activities.
• GMP knowledge: strong working knowledge of current Good Manufacturing Practices.
• Aseptic experience: experience within controlled cleanroom environments under aseptic conditions is a plus.
• Project management: ability to manage activities, priorities and reporting in a structured way.
• Fluency in Dutch and English (written and spoken).

Responsabilités

• Define, plan and coordinate validation activities including PPQ, smoke studies, hold time validation, APQ and APS.
• Provide technical guidance on validation and qualification activities.
• Ensure timely revalidation of manufacturing and sterilisation processes.
• Write, review and approve validation plans, protocols and reports.
• Participate in product transfer and manufacturing system introduction activities.
• Contribute to optimisation projects for manufacturing systems and processes.
• Review technical documentation against regulatory requirements and current industry practices.
• Provide accurate progress updates to stakeholders and leadership.
• Lead validation activities for advanced cell therapy and related GMP computerised systems.
• Support tech transfer and manufacturing process activities.

Connaissances

Process validation

Regulatory compliance

GMP

Project management

Aseptic environments

Cross-functional collaboration

Formation

Bachelor degree or higher in engineering/biotech/biomedical/pharmacy

Description du poste

MindCapture BV is seeking a Process Validation Engineer for Cell Therapy to coordinate validation activities in a new manufacturing environment. You will oversee validation strategy, approvals, and documentation while ensuring GMP compliance and regulatory alignment.

Ideal candidates hold a technical degree and have experience in regulated pharma/biotech settings, including sterile environments and technology transfer.