Validation Engineer CSV - Geel - Oxford Global Resources

    Oxford Global Resources
    Oxford Global Resources Geel

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    Beschrijving

    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.

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