• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • [email protected]
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     [email protected]
  • Validation Engineer – Co. Waterford

    Role Summary:


    • A new opportunity has arisen for a Validation Engineer based on our client’s busy pharmaceutical site in Co. Waterford.
    • The Validation Engineer has a key role in ensuring the on-going validation compliance of equipment, systems and processes on site in both solid dosage forms and sterile products manufacturing.


    Core Duties and Responsibilities:


    • Integrally involved in the validation of all new equipment, processes and control systems on site.
    • Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, and computerised systems.
    • Participates in the change control process advising on validation issues, as appropriate
    • Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
    • Ensures projects are managed in compliance with all required site and legal requirements (Health & Safety, cGMP, construction, environmental etc).
    • Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
    • Provide technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing and sterilisation.
    • Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
    • Maintain validation documentation through the
      • Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.
      • Generate/review/approve execution of the validation/revalidation plans.
    • Review and approval of site change controls
    • Ensure compliance to cGMP at all times.


    Minimum Qualifications and Experience:


    • Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
    • Post-graduate studies as appropriate to augment primary degree
    • 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
    • 2-3 years experience in validation environment
    • Project Management Experience
    • Capable of troubleshooting validation issues associated with projects, process development etc.
    • Competent technical knowledge of pharmaceutical plants.
    • Knowledge of requirements for of GAMP, ISPE Baseline guides.
    • Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
    • Full understanding of relevant quality and compliance regulations
    • Able to execute projects to plan.


    To Apply: Quote – PE23080


    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, Cork, T23 KC67, Ireland.

    +353 21 2066178
    [email protected]

    Click here to submit your CV

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