CSV Validation Engineer (PAS-X) – Life Sciences

Vulcain Engineering Group | Belgium

Vlaams-Brabant

Sur place

EUR 50 000 - 58 000

Plein temps

Il y a 6 jours

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Avantages offerts par ce poste

Company car

Fuel card

Meal vouchers

Insurance

Eco cheques

Sectorial bonus

Résumé du poste

Vulcain Engineering Group in Belgium is seeking a CSV Validation Engineer (PAS-X) to lead validation activities for GMP-regulated systems, ensuring data integrity and GxP compliance across MES implementations in regulated manufacturing environments.

You will prepare and review validation plans, risk assessments, IQ/OQ/PQ protocols, coordinate testing with manufacturing, QA and IT, and support audits while driving continuous improvement of validation methodologies and digitalization of production

Qualifications

Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology or related field.
4+ years of validation experience in pharma/Life Sciences.
Experience with PAS-X MES projects.
Strong CSV, GAMP5 and GMP knowledge.
Experience writing and executing validation protocols.
Knowledge of data integrity and CSV lifecycle management.
Ability to work autonomously with multidisciplinary stakeholders.
Fluency in English; Dutch a plus.

Responsabilités

Lead CSV activities for GMP-regulated systems.
Implement, qualify and manage PAS-X MES solutions.
Prepare and review validation documentation (IQ/OQ/PQ, URS, DS, DS, validation reports).
Ensure data integrity and GxP compliance.
Coordinate testing and defect management during projects.
Collaborate with manufacturing, QA, IT and engineering teams.
Support audits and inspections; ensure inspection readiness.
Drive continuous improvement of validation methodologies and digitalization.