CQV Engineer, Life Sciences — Global Validation Lead

Capgemini

Diegem

Sur place

EUR 55 000 - 90 000

Plein temps

Il y a 22 heures

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Résumé du poste

Capgemini Engineering is seeking a focused CQV Engineer to ensure quality, compliance, and validation of critical systems in the Life Sciences sector in Diegem. You will develop IQ/OQ/PQ protocols, lead CQV activities on projects from facility builds to upgrades, and collaborate across engineering, QA, and operations to meet timelines and regulatory expectations.

The role requires at least 2 years in commissioning/qualification/validation, strong GMP knowledge, and a degree in Engineering or

Qualifications

A minimum of 2 years of experience in commissioning, qualification, and/or validation within the Life Sciences industry.
Strong knowledge of GMP regulations and guidelines such as FDA 21 CFR, EU GMP Annex 15, and GAMP 5.
Excellent communication and collaboration skills within multidisciplinary teams and with clients.
A degree in Engineering, Life Sciences, or a related field.
Proficiency in French and/or Dutch, as well as English.

Responsabilités

Develop and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, and manufacturing systems.
Lead CQV activities across projects, from new facility builds to equipment upgrades.
Collaborate with engineering, quality assurance, and operations to align with timelines and client expectations.
Prepare and review validation master plans, risk assessments, deviation reports, and summary reports for regulatory compliance.
Support regulatory inspections and audits by providing audit-ready CQV documentation.