Equipment Validation Engineer Kent Hybrid Remote - Cranleigh Scientific Ltd

    Cranleigh Scientific Ltd
    Cranleigh Scientific Ltd Kent, United States

    1 month ago

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    Description
    A Coatings Company is currently seeking an Equipment Validation Engineer/Officer to join the team.

    This pivotal role involves spearheading the creation, development, and support of validation processes, as well as implementing ongoing optimization and harmonization strategies for production-scale manufacturing equipment.

    Successful candidates will bring a proven track record in production-scale validation, with specific experience in powder blending or handling active ingredients considered advantageous.

    This is a hybrid opportunity.


    MAIN RESPONSIBILITIES:


    Assist in creating, developing and providing support for validation and ongoing optimisation and harmonisation strategies for production scale product manufacturing-related equipment.

    Assist in creating process validation and equipment qualification protocols and reports (which may include FAT).
    Assist with review of qualification/validation protocols including support to global manufacturing sites.

    Assist in maintaining the status of global master specifications for manufacturing equipment, and the global master manufacturing documentation for excipient blends.

    Prepare validation, stability and qualification protocols and subsequent reports.
    Assist with the evaluation & validation of raw materials from both current and new suppliers.
    Assist in trials carried out with suppliers and/or customers.
    Formally stability test products containing these raw materials.

    EXPERIENCE REQUIRED
    Essential
    Degree (or equivalent) in science or engineering-related qualification.
    Proven experience in the Validation of Equipment in a manufacturing environment.
    Proven validation experience within a highly regulated manufacturing environment (Medical Devices, Pharmaceuticals, Food etc.).
    Knowledge & experience of excipient blend products and raw materials
    Report Writing
    Desirable
    Experience in process development, optimization, scale-up & validation studies
    Experience in equipment evaluation & qualification studies
    Proven knowledge and experience of Change Control and Risk Management processes.
    Knowledge and experience of EXCiPACT and/or ISO 9001 requirements is highly advantageous.
    ISO / GMP / GLP /COSHH / H&S awareness

    This is a hybrid opportunity with the added benefit of a flexi-time scheme.

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