• 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
  • Process Engineer (MFFL) – Co. Waterford

    Role Summary:

     

    • A new vacancy has arisen for a Process Engineer (MFFL) at our client’s busy pharmaceutical site in Co. Waterford.
    • The successful candidate will provide support to the Multi Format Filling Line (MFFL) line for the aseptic processing of monoclonal antibody (mAb) commercial products.
    • The Process Engineer will support technology transfer of new products and work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

     

    Core Duties and Responsibilities:

     

    • Support Qualification of new equipment into commercial manufacturing
    • 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.
    • Investigation/trouble shooting and solution implementation on process and equipment deviations using GPS3 problem solving tools
    • 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.

     

    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.
    • Excellent communication and interpersonal skills.
    • Strong Technical Writing, 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 – PE22110

     

    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, R95 F727, 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.