• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland +353 21 206 6178 info@prochem.ie
  • Senior CSV Engineer – Meath

    Role Summary:


    • The CSV Engineer will be responsible for delivery of Automation and IT scope on one or more projects in the portfolio of capital projects.
    • This candidate will be required to work closely with the teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.


    Core Duties and Responsibilities:


    • Partner with local project teams to deliver Automation and IT aspects of capital projects
    • Liaise with site AIT group to add input to site SOP’s
    • Author\Review\Approval of qualification lifecycle documents for process\lab systems – RS, CS, RTM etc…
    • Work with site teams on generation of requirement and\or configuration specification, design specifications and test protocol
    • Protocol generation, execution and approval
    • Maintain Inventory and control upgrades to PLC/SCADA/DCS system
    • Generate any automation change control documentation required for introducing new systems or modifying existing systems.
    • Generate any risk assessment\variance documentation and interface with above site team to close out same
    • Work closely with the QAIT function to ensure compliance with MSD Quality standards.
    • Interface with above site teams for deliverables of Enterprise systems as required
    • Ensures that SDLC is appropriately applied


    Minimum Qualifications and Experience:


    • BS in Engineering, Computer Science, or other technical degree.
    • 3 or more years of experience in project/automation/IT support in a similar role.
    • Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
    • Excellent facilitation, problem solving, and decision-making skills.
    • Excellent understanding of cGMP’s, SDLC methodologies and LEAN/MPS/ Sigma principles
    • Proven facilitation, meeting/workshop management, project management and change management skills are essential.
    • Excellent written and oral communication skills, as well as strong presentation skills.
    • Demonstrated ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential
    • Experience in PLC/SCADA/DCS systems


    To Apply:

    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:


    Click here to submit your CV

    Please note, we do not require agency assistance with this role.