Life Sciences Quality Engineer — GMP & Regulatory Expert

Capgemini Engineering; Diegem; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Free access to learning platforms

Mentoring programs

Global engineering opportunities

Job summary

Capgemini Engineering, a global leader in engineering services, seeks a Quality Engineer for Life Sciences. You will contribute to Quality Management systems, regulatory compliance, and continuous improvement across pharma and biotech environments.

You will collaborate with cross-functional teams, lead QA/QC activities, and ensure audit readiness for FDA, EMA, and other bodies. Fluency in French/Dutch and English is preferred in Brussels' multilingual setting.

Qualifications

• 2+ years in quality assurance or quality engineering in Life Sciences (pharma/biotech/medical devices).
• Strong knowledge of GMP and ISO 13485, FDA 21 CFR, EU GMP, ICH guidelines.
• Experience with root cause analysis, risk management, CAPA implementation.
• Proactive, detail-oriented, and focused on quality and patient safety.
• Proficiency in French and/or Dutch plus English for Brussels multilingual environment.

Responsibilities

• Develop, implement, and maintain QMS per GMP and regulatory frameworks.
• Lead QA/QC activities: batch review, product release, change control, deviations, CAPA.
• Conduct internal and external audits to ensure regulatory compliance.
• Collaborate with manufacturing, validation, regulatory, and supply chain teams.
• Prepare and review SOPs, risk assessments, audit reports, and quality metrics.

Skills

Quality engineering

GMP compliance

Analytical thinking

Problem solving

Multilingual (French/Dutch/English)

Education

Engineering, Life Sciences, Pharmacy degree

Job description

Capgemini Engineering, a global leader in engineering services, seeks a Quality Engineer for Life Sciences. You will contribute to Quality Management systems, regulatory compliance, and continuous improvement across pharma and biotech environments.

You will collaborate with cross-functional teams, lead QA/QC activities, and ensure audit readiness for FDA, EMA, and other bodies. Fluency in French/Dutch and English is preferred in Brussels' multilingual setting.