CSV Validation Engineer - Computerized Systems

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

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.