• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • CQV Engineer – Co. Waterford

    Role Summary:


    • Our client is looking for a CQV (Commissioning, Qualification, and Validation) Engineer to join their busy pharmaceutical site in Co. Waterford.
    • The CQV Engineer will be working as part of the client’s Data Integrity Programme.
    • This position is an ongoing contracting opportunity.


    Core Duties and Responsibilities:


    • Documenting User Access Matrix (UAM) for Critical Systems
    • Developing Data Flow Diagrams (DFD) as a deliverable of Data Integrity Maturity Model (DIMM)
    • Analysing Audit Trail Reviews (ATR) as a deliverable of Data Integrity Maturity Model (DIMM)
    • Documenting Audit Trail Review requirements (ATR) as a deliverable of Data Integrity Maturity Model (DIMM)
    • Supporting Data Integrity Risk Assessments (DIRA)
    • Alignment with Compliance teams on requirements for Audit Trail Review (ATR) on Critical Systems
    • Supporting Project Team in delivering the requirements of the Data Integrity Maturity Model (DIMM) program
    • Working with QC / Manufacturing personnel to document above requirements


    Minimum Qualifications and Experience:


    • Degree qualified in relevant engineering/technical discipline required.
    • Experience with DI / CSV / Validation required.
    • Relevant experience in a pharmaceutical environment preferred.
    • Excellent communication skills (interpersonal, presentation & writing).
    • Ability to effectively communicate technical & non-technical information.
    • Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment.
    • Initiative – able to work in a self-directed manner to see issues through to completion.
    • Highly motivated and has the ability to multi-task.


    To Apply:


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

    GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.

    +353 21 2066178

    Click here to submit your CV

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