GMP QA Qualification Engineer – Cell Therapy

MindCapture BV; Beerse; On-site; EUR 65,000 - 85,000; Full time

Job summary

MindCapture BV in Belgium is seeking a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment within a GMP environment. You will safeguard qualification status, review deviations, and support health authority inspections as a QA qualification representative, collaborating across manufacturing and quality functions.

The role emphasizes strong quality awareness, knowledge of GMP guidance for cell therapy, data integrity, and effective

Qualifications

• Master’s degree in engineering with a chemistry/analytical background or pharmaceutical sciences.
• GMP regulations knowledge and relevant European/US guidance for cell therapy manufacturing.
• Ability to defend qualification strategies and documentation during health authority inspections.
• Affinity with computerised systems and data management for critical production assets.
• Strong communication across departments in a changing environment.
• Fluency in Dutch and English, both spoken and written.

Responsibilities

• Review and approve qualification and requalification activities for facilities, utilities and process equipment.
• Safeguard qualification status of critical production assets by identifying, qualifying and controlling requirements.
• Evaluate deviations with potential quality or compliance impact; ensure investigations with CAPAs.
• Collaborate with manufacturing to review and approve change controls and quality deviations.
• Maintain qualification and compliance standards with other quality functions.
• Manage compliance status through calibration docs, master data, maintenance plans and records.
• Review data integrity deliverables including audit trails and user access reviews.
• Support regulatory and customer inspections and act as QA qualification representative.
• Review and approve qualification documents: protocols, reports, procedures, rationales and related actions.
• Participate in system and process improvement initiatives while maintaining quality and compliance.

Skills

Quality mindset

GMP knowledge

Qualification strategies

Computerised systems

Communication skills

Dutch and English

Analytical thinking

Risk assessment

Education

Master’s degree in engineering with chemistry/analytical background or pharmaceutical sciences

Job description

MindCapture BV in Belgium is seeking a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment within a GMP environment. You will safeguard qualification status, review deviations, and support health authority inspections as a QA qualification representative, collaborating across manufacturing and quality functions.

The role emphasizes strong quality awareness, knowledge of GMP guidance for cell therapy, data integrity, and effective