CQV Engineer, Life Sciences — Validation Lead (FlexAbroad)

Capgemini Engineering; Diegem; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

FlexAbroad

Learning platforms access

Résumé du poste

Capgemini Engineering is seeking a CQV Engineer to ensure quality, compliance and validation of critical Life Sciences systems and processes. You will lead CQV activities across projects from new facilities to upgrades, working with cross-functional teams to meet timelines and regulatory expectations.

The role requires 2+ years in commissioning/qualification/validation in pharma/biotech/medical devices, strong GMP knowledge, and fluency in French and/or Dutch plus English for Brussels'

Qualifications

• Minimum 2 years in commissioning, qualification and/or validation within Life Sciences (pharma/biotech/medical devices).
• Solid GMP knowledge with FDA 21 CFR, EU GMP Annex 15, GAMP 5 and practical application.
• Excellent communication and collaboration across multidisciplinary teams and clients.
• Multilingual: French and/or Dutch plus English for Brussels environment.

Responsabilités

• Developing and executing validation protocols (IQ/OQ/PQ) for equipment, utilities and systems.
• Leading CQV activities across projects from new facilities to upgrades; ensure timely, compliant delivery.
• Collaborating with engineering, QA, and operations to align validation with timelines and client expectations.
• Preparing and reviewing validation master plans, risk assessments, deviation and summary reports for regulatory readiness.
• Supporting regulatory inspections and audits with technical expertise and audit-ready CQV documentation.

Connaissances

GMP knowledge

Validation experience

Strong communication

Engineering degree

Languages FR NL EN

Formation

Engineering or Life Sciences degree

Description du poste

Capgemini Engineering is seeking a CQV Engineer to ensure quality, compliance and validation of critical Life Sciences systems and processes. You will lead CQV activities across projects from new facilities to upgrades, working with cross-functional teams to meet timelines and regulatory expectations.

The role requires 2+ years in commissioning/qualification/validation in pharma/biotech/medical devices, strong GMP knowledge, and fluency in French and/or Dutch plus English for Brussels'