GMP Cell Therapy QA Qualification Engineer

MindCapture; Gent; Sur place; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

DKV health insurance

Group insurance

Expense allowance

Company car

Training & development

Résumé du poste

MindCapture seeks a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment in a GMP environment. In this consultancy role you will oversee qualification programs and ensure data integrity and change controls are managed to maintain compliant production assets.

You will collaborate with manufacturing and quality teams, support inspections, review protocols and reports, and contribute to continuous improvement initiatives.

Qualifications

• Master’s degree in engineering with a chemistry or analytical background or in pharmaceutical sciences.
• Strong GMP knowledge and regulatory guidance for cell therapy manufacturing (EU/US).
• Ability to defend qualification strategies and documentation during inspections.
• Experience with computerised systems and data management for critical assets.
• Excellent communication and cross-department collaboration in a changing environment.
• Fluency in Dutch and English (spoken and written).
• Analytical thinking with risk assessment and clear communication.
• Strong collaboration and teamwork skills.

Responsabilités

• Review and approve qualification and requalification activities for facilities, utilities and process equipment.
• Safeguard the qualification status of critical production assets by ensuring requirements are identified, qualified and controlled.
• Evaluate equipment-related deviations with potential quality or compliance impact and ensure thorough investigations with corrective actions.
• Work with manufacturing stakeholders to review and approve change controls and quality-related deviations.
• Collaborate with quality functions to maintain qualification and compliance standards.
• Manage calibration documentation, master data, maintenance plans and records for critical assets.
• Review and approve data integrity deliverables including system audit trails and user access reviews.
• Support regulatory and customer inspections and act as a QA qualification representative.
• Review qualification documents including protocols, reports, procedures and corrective actions.
• Participate in system and process improvement initiatives while ensuring quality and compliance.

Connaissances

Strong communication skills

Analytical thinking

Risk assessment

Collaboration / teamwork

Formation

Master’s degree in engineering (chemistry/analytical) or pharmaceutical sciences

Outils

Computerised systems experience

Description du poste

MindCapture seeks a QA Qualification Engineer to drive qualification activities for facilities, utilities and process equipment in a GMP environment. In this consultancy role you will oversee qualification programs and ensure data integrity and change controls are managed to maintain compliant production assets.

You will collaborate with manufacturing and quality teams, support inspections, review protocols and reports, and contribute to continuous improvement initiatives.