• Technical Validation SME

    • ID:893596
    • Location: Midlands, Ireland
    • Category:Validation Lead
    • Positions Available:1


    Our Client, a large bulk product manufacturing facility in the Midlands in Ireland, currently require the support of a Technical Validation SME to work on a new Upstream facility at their existing site which is a new facility with 2 floors constructed in 2016. This project will occupy one of those floors.

    Reporting to the Senior Manager for Validation, this engineer will act as the link between the project and the Validation Manager and will take on an oversight & documentation focussed role in this regard.

    • Act as the link between the project and the validation manager with regard to validation master plan, etc
    • Provide technical strategy support as an SME and managing technical queries around this
    • Review high level documents such as deviations etc.
    • If any validation queries arise, the SME will be required to ensure that written documentation is correct, ensure that the correct templates have been set up and
    have been used and ensure that the correct regulatory guidelines have been followed
    • Offer expertise and guidance for any validation execution queries that may arise

    • Degree in Engineering or similar
    • 10+ years experience in biopharma
    • Knowledge of systems such as Downstream Purification, Single Use, etc would be a distinct advantage
    • Experience in working on large bio projects preferred
    • Solid understanding of the biopharma industry
    • Excellent grasp of GDP
    • Positive, can-do attitude
    • Solutions focussed

    • Start: ASAP – Jan 2020
    • Contract Term: 12 months
    • Hours per week: 45 hours