QA Qualification Engineer

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

Drive quality and compliance for advanced cell therapy manufacturing as a QA C and Q Engineer. In this consultancy role, you will oversee qualification activities for critical facilities, utilities and process equipment while supporting a highly regulated manufacturing environment.

Ready to grow your career and make real impact? Join MindCapture as a QA Qualification Engineer and contribute to impactful healthcare projects in a GMP environment.

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 pharma industry.

Job Description:

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

Requirements:

• Master’s degree in engineering with a chemistry or analytical background or in pharmaceutical sciences
• Strong quality awareness with knowledge of current GMP regulations and relevant European and US regulatory guidance for cell therapy manufacturing
• Ability to support and defend qualification strategies and documentation during health authority inspections
• Affinity with computerised systems, system parameter configurations and data management for critical production assets
• Strong communication skills with the ability to collaborate effectively across departments in a continuously changing environment
• Thorough knowledge of Dutch and English, both spoken and written
• Strong analytical thinking, risk assessment and communication capabilities