Validation Engineer CSV

Job Title: Validation Engineer – Computerized Systems Validation (CSV)

Location: Belgium (On-site, full-time)

Duration: 6 months

Description:

We are seeking a Validation Engineer with hands-on experience in validating cGMP-critical computerized systems . The role involves development, implementation, and execution of URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities, ensuring compliance with cGMP, user, and regulatory requirements.

Key Accountabilities:

• Develop, implement, and execute validation studies and documentation (protocols/reports) for computerized systems.
• Manage validation documentation through approval and implementation.
• Perform system validation where industry precedence exists but standards require interpretation.
• Ensure validated status of systems is compliant with cGMP at all times.
• Manage projects in line with Sanofi and regulatory standards.
• Stay current on emerging validation regulations and provide technical assistance regarding US FDA and EU requirements.
• Review and assess changes impacting validated status and documentation.
• Investigate and troubleshoot validation issues.

Skills / Experience:

• Strong communication skills and ability to work independently.
• Proven capability to execute projects according to plan.
• Competent knowledge of Computer Systems Validation.
• Full understanding of quality and compliance regulations.
• Minimum 3 years of experience in pharmaceutical sector and GMP environment.
• Good command of English and Dutch .
• Experience with DCS systems (Emerson DeltaV) is an advantage.

If you are interested or know someone suitable, please share your CV and contact details to schedule a call and receive further details.