• 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
  • Validation Engineer – Co. Dublin

    Role Summary:

     

    • A new opportunity has arisen for a Equipment / Packaging Validation Engineer at our client’s busy pharmaceutical facility in Co. Dublin.
    • Reporting to the Engineering Director or assigned line manager.
    • The overall objective of this role is to partake, validate and support a portfolio of project activities on site including new process installations, process modifications and process improvements relating to manufacturing, facility & packaging operations unit.
    • Which could involve involvement in preliminary & detailed design, detailed project plans, regulatory compliance, validation and installation of equipment, progress updates & KPI’s, and the overall support of projects safely, in compliance, on time, in full & within budget with local and external teams.

     

    Core Duties and Responsibilities:

     

    • Supporting capital projects team for on-site based projects for Oral Solids Dose Manufacturing, Facilities and Packaging operations.
    • Perform activities in support of the validation program such as risk assessments and review and assessment of development data in line with recognised standards.
    • Is responsible for development, approvals control, execution and closure of the Validation Project plan for all tests.
    • Responsible for retrospective reviews and update of existing validation system or documents.
    • Liaise with Manufacturing / Packaging/ Facilities Engineering and end users on the completion of risk assessment for any product line extensions, process improvements or automation projects.
    • Verifies that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Validation Plan and Protocols.
    • Provides information on relevant regulations and internal process validation policy with regards to equipment / process validations and qualifications.
    • Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation / Engineering Team.
    • Provides guidance in closing out noncompliance and deviations in relation to Validations.
    • Provides assistance and ensures the preparation of validation protocols, process design specifications and associated documentation for equipment and systems.
    • Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.
    • Works with teams and other departments across the plant to ensure project adherence.
    • Acts as an effective team member in supporting quality disciplines, decisions, and practices.
    • Applies sound, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
    • Control and compliance of Calibration schedules and associated instruments.
    • Develop and maintain existing and future document control practices.

     

    Qualifications and Experience:

     

    • A bachelor’s degree in engineering.
    • Minimum 2-5 years’ experience in a Pharmaceutical / Food role as a Validation Engineer
    • Background in Oral Solid dose Manufacturing & Packaging would be advantageous.
    • Must possess excellent technical writing ability
    • Strong documentation skills
    • Have the capacity to work on own initiative and as part of a team.
    • Possess strong interpersonal and communication skills
    • Must work to the highest engineering standards
    • Have strong technical and problem-solving skills
    • Experience in cGMP, general packaging systems and serialization is advantageous.
    • Will require some travel within Europe, depending on project but will be minimal.

     

    To Apply:

     

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

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100
    recruitment@prochem.ie

    Click here to submit your CV

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