CQV Engineer, Life Sciences — Validation & Compliance

Capgemini Engineering; Diegem; On-site; EUR 55,000 - 85,000; Full time

Job summary

Capgemini Engineering in Belgium is seeking a CQV Engineer to ensure quality, compliance and validation of critical systems and processes within the Life Sciences sector. You will support validation activities across projects from new facilities to upgrades.

You will develop IQ/OQ/PQ protocols, lead commissioning, review technical docs, and collaborate with engineering, quality assurance and operations to ensure audit-ready records and timely delivery.

Qualifications

• Minimum 2 years in commissioning, qualification, and/or validation in Life Sciences (pharma/biotech/medical devices).
• Strong GMP knowledge: FDA 21 CFR, EU GMP Annex 15, GAMP 5.
• Excellent communication and collaboration across cross-functional teams.
• Engineering or Life Sciences degree with proactive problem-solving mindset.
• Proficiency in French and/or Dutch and English.

Responsibilities

• Developing and executing validation protocols (IQ, OQ, PQ) for equipment, utilities, and manufacturing systems.
• Leading and supporting commissioning, qualification, and validation activities across projects, ensuring timely and compliant delivery.
• Collaborating with engineering, quality assurance, and operations to align validation with project timelines and client expectations.
• Preparing and reviewing validation master plans, risk assessments, deviation reports, and summary reports for regulatory compliance.

Skills

CQV/Commissioning

Validation

GMP knowledge

Regulatory compliance

Multilingual

Education

Engineering degree

Life Sciences degree

Job description

Capgemini Engineering in Belgium is seeking a CQV Engineer to ensure quality, compliance and validation of critical systems and processes within the Life Sciences sector. You will support validation activities across projects from new facilities to upgrades.

You will develop IQ/OQ/PQ protocols, lead commissioning, review technical docs, and collaborate with engineering, quality assurance and operations to ensure audit-ready records and timely delivery.