• 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
  • Project MES Engineer – Co. Carlow

    Role Summary:

     

    • A new vacancy has arisen for the role of a MES Engineer at our client’s busy pharmaceutical site in Co. Carlow.
    • Reporting to the MES Lead, The MES Engineer will be responsible for supporting the delivery of an expansion to existing MES system (Werum PasX).
    • The MES engineer will participate in the development of key AIT quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuing adherence to all Automation documentation.
    • This candidate will be required to work closely with the site AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
    • This candidate will review and ensure vendors compliance with site quality standards.
    • He/she will represent the MES function at AIT and other site project meetings, as required.

     

    Core Duties and Responsibilities:

     

    • Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
    • Develop templates for all SDLC deliverables, compliant with site standards, to ensure consistent implementation of the validation strategy, including but not limited to:
      • Requirements Specification
      • Requirements Traceability Matrix
      • Functional Specification
      • Design Specification
      • Code Review
      • Test specification/test script
      • Etc.
    • Work closely with the QAIT (Quality) function and ensure their requirements are met in all deliverables
    • Generate and Execute AIT SDLC deliverables, ensuring compliance with standards
    • Provide FAT oversight and perform leveraging assessments
    • Provide guidance and support to AIT team members tasked with delivery of SDLC documents
    • Provide input to the development of realistic project schedules and document trackers
    • Work closely with suppliers / integrators to ensure compliance with site standards
    • Participate in, and support, relevant project meetings
    • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.
    • Shift work maybe introduced and if so, you will be expected to work shift hours. Shift pattern will be open to change depending on business requirement.

     

    Minimum Qualifications and Experience:

     

    • Relevant Computer Science or Engineering degree or equivalent.
    • Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
    • Expert knowledge of GAMP5.
    • Strong experience in one or all of the following systems: MES Werum PasX OSI PI.
    • Fluent in English, written and verbal.
    • Usual place of work will be on site in Co. Carlow Ireland. The successful candidate may sometimes be required to attend meetings at other company sites or Vendor sites.
    • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
    • Strong interpersonal and communication skills (verbal and written).

     

    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.