• Senior CSV Engineer

    Location : Location IE--
    Job ID
    2020-1899
    Category
    CQV
  • Overview

    PM Group wish to recruit a Senior CSV Engineer to join our Bio-pharmaceutical cient based in Sligo. Excellent hourly rate on offer.

    Responsibilities

    • Ensure all CSV equipment is qualified in compliance with Data Integrity policies and regulatory requirements.
    • Investigation of software related deviations and non-conformances as part of quality team.
    • Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
    • Generation/maintenance of the site wide validation master plans.
    • Generation of validation plans, protocols and final reports to cGMP standard.
    • Review / approval of all protocols and final reports and participation of testing and commissioning.
    • Management of validation change control process.
    • Provide technical expertise and be the site point of contact for CSV

    Qualifications

    • Third level qualification in relevant engineering / science discipline
    • Minimum of 4 year’s experience in a similar CSV role.
    • Ability to demonstrated leadership and ownership qualities in all activities related to CSV.
    • Prior experience working in a highly regulated environment

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