QA C&Q Engineer (Pharmaceuticals)

TL;DR

QA C&Q Engineer (Pharmaceuticals): Reviewing and approving qualification activities for facilities, utilities, and process equipment within a CAR-T cell therapy manufacturing hub with an accent on cGMP compliance and data integrity. Focus on managing the qualification status of critical production assets and ensuring adherence to FDA/EU guidelines during regulatory inspections.

Location: Must be based in the Ghent area or Beerse, Belgium

Company

An independent technology consulting firm providing guidance and solutions across Information Systems, Telecom, Life Sciences, and Engineering.

What you will do

• Review and approve qualification and requalification activities for Facilities & Utilities (F&U) and Process Equipment.
• Guard the qualification status of critical production assets and implement mitigation plans.
• Investigate equipment-related deviations and define appropriate corrective and preventive actions (CAPA).
• Manage compliance by reviewing calibration records, SOPs, and data integrity deliverables.
• Collaborate with manufacturing departments to review and approve new change controls.
• Act as the QA Qualification spokesperson during regulatory and customer inspections.

Requirements

• Master’s degree in Engineering (chemistry/analytical background) or Pharmaceutical Sciences.
• 4–6 years of experience in a GMP-regulated environment (biotech or pharma).
• Strong knowledge of cGMP regulations and FDA/EU guidance for cell therapy products.
• Fluency in Dutch and English is mandatory.
• Proficiency in data integrity principles and computerized system configurations.

Nice to have

• Experience specifically within cell or gene therapy.

Culture & Benefits

• Rapid growth opportunities within a fast-expanding Belgian workforce.
• Opportunity to work on impactful missions with prestigious pharmaceutical and biotechnology clients.
• Agile, dynamic, and international environment promoting intrapreneurship and meritocracy.
• Commitment to diversity and an inclusive workplace.

Hiring process

• Brief introductory virtual or phone call.
• Average of three interviews with line managers and future teammates.
• Possible case study, technical assessment, or role play depending on the role.