Validation Engineer CSV - W/M/X

MANTU GROUP SA; Geel; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

MANTU GROUP SA in Belgium is seeking a Validation Engineer – Computerized Systems to plan, execute and maintain validation activities for cGMP‑critical software packages and computerized systems, ensuring ongoing validated state and compliance with regulatory expectations.

You will prepare validation documentation, collaborate with QA, IT and engineering, interpret FDA/EU guidelines and drive improvements while supporting reliable manufacturing and laboratory operations.

Qualifications

• Minimum 3 years of experience in the pharmaceutical GMP environment.
• GxP and data integrity knowledge, FDA/EU guidelines.
• Experience validating software and computerized systems from planning to documentation.

Responsabilités

• Plan, execute and maintain validation activities (URS, SIA, DQ, IQ, OQ, PQ, RV, TM) for computerized systems in a cGMP environment.
• Prepare validation documentation (protocols and reports) and support hands-on execution of validation protocols.
• Ensure validation documentation is reviewed, approved and implemented, maintaining systems in a validated state.
• Perform validation of systems with industry standards, interpreting cGMP, cGLP and internal procedures.
• Ensure projects comply with Sanofi procedures and regulatory standards.
• Stay current on validation regulations; provide input on US FDA and EU requirements.
• Assess changes for impact on validation status and documentation; define required activities.
• Investigate and troubleshoot validation issues with corrective actions.

Connaissances

GxP knowledge

Validation of computerized systems

Regulatory compliance

Fluent English and Dutch

Independent working

Strong communication

Troubleshooting

Description du poste

As a Validation Engineer – Computerized Systems, you will be responsible for planning, executing and maintaining validation activities for cGMP‑critical software packages and computerized systems. You will ensure systems remain in a validated state, compliant with cGMP, regulatory expectations and internal procedures, directly supporting reliable and compliant manufacturing and laboratory operations

Your missions

• Develop, implement and execute validation activities (URS, SIA, DQ, IQ, OQ, PQ, RV, TM) for computerized systems in a cGMP environment.
• Prepare validation documentation (protocols and reports) and support/perform hands‑on execution of validation protocols.
• Ensure validation documentation is properly reviewed, approved and implemented, maintaining systems in a validated state at all times.
• Perform validation of systems with existing industry precedence, interpreting standards for the specific case in line with cGMP, cGLP and internal procedures.
• Ensure projects are managed in compliance with Sanofi procedures and applicable cGMP and regulatory standards.
• Stay current on emerging validation regulations and practices; provide technical input on US FDA and EU requirements.
• Assess changes for impact on validated status and validation documentation, and define required validation activities.
• Investigate and troubleshoot validation issues, proposing and implementing appropriate corrective actions.

Your profile

• Minimum 3 years of experience in the pharmaceutical sector and GMP environment.
• Solid knowledge of Computer Systems Validation and relevant quality/compliance regulations (e.g. GxP, data integrity, FDA/EU guidelines).
• Experience validating software packages and computerized systems, from planning to execution and documentation.
• Strong troubleshooting skills for validation and system issues.
• Able to work independently, learn quickly and execute projects according to plan.
• Strong communication skills, able to interact with QA, IT, engineering and business stakeholders.
• Good command of English and Dutch (spoken and written).

What we offer

Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression.

In practical terms, here’s what this means for you on a daily basis:

Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth.
Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts.
A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged.
Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.
CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3