• 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]
  • Process Engineer – Co. Waterford

    Role Summary:


    • A fantastic opportunity has arisen for a Process Engineer based on our client’s busy pharmaceutical site in Co. Waterford.
    • The successful candidate will support the qualification of new equipment into commercial manufacturing.
    • In this role you will execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.


    Core Duties and Responsibilities:


    • Investigation/trouble shooting and solution implementation on process and equipment deviations using GPS3 problem solving tool.
    • Monitoring and review of equipment cycle trends using PI application
    • Assist in the implementation of capital projects
    • Implement and monitor performance metrics.
    • Lead technical problem resolution & RCA (Root Cause Analysis) for all manufacturing operations, in conjunction with cross functional teams.
    • Lead cycle time reduction initiatives in conjunction with manufacturing teams
    • The main area of work would be on the Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
    • Lead Process Engineering tech transfer activities for product introduction / transfer to the MFFL Line.
    • Provide engineering support to other areas of the MFFL process such as Dispensing, Formulation, Autoclaving and Washing.
    • Provide technical support to implement process improvements, new product transfers to the site and production.
    • Design and implement Process development programs through plant trials, execution and change implementation
    • Constantly seek to challenge operational standards and driving continuous improvement.


    Minimum Qualifications and Experience:


    • Honours degree in an Engineering discipline.
    • Strong problem-solving skills.
    • 3 or more years’ relevant experience in a highly regulated GMP environment.
    • Experience of Sterile Manufacturing Operations would be an advantage. Experience in syringe filling would be a distinct advantage.
    • Good knowledge of quality management systems.
    • Excellent communication skills.
    • Strong interpersonal skills and leadership skills.
    • Strong technical writing skills,
    • Strong coordination, project management and planning skills.
    • Customer-focused decision-making skills.
    • Strong understanding of maintenance, reliability, safety, quality and regulatory.
    • Experience with change control, deviation management and associated compliance activities and systems.


    To Apply: Quote – PE23053


    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.