MES Operations Analyst

  • Location:

    Munster, Republic of Ireland

  • Sector:

    Engineering

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Job ref:

    BBBH101143_1555489777

  • Published:

    9 days ago

  • Start date:

    ASAP

  • Client:

    Undisclosed Company

MES Operations analyst



Summary:
An MES Operations analyst is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.
Responsible for the Design and Configuration of the Manufacturing Execution Systems (MES) manufacturing Batch Records and Equipment data. The successful individual is responsible for eliciting and documenting manufacturing business processes requirements

Essential Duties and Responsibilities:

  • Design and deploy MES system (Werum's PAS-X) to replace paper based process or manual processes in the processing areas
  • Coordinates the needs of functional departments and establishes priorities for MES User requirements gathering, system design and implementation
  • Actively participate in project deliverables such as Review of company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess requirements for designing electronic records
  • Design and develop MES recipes, workflows, Equipment, Master Data and electronic batch records to meet the requirements of the Business, specifically Manufacturing and QA
  • Participates in the Creation and Testing of MES related protocols
  • Responsible for maintaining MES design documentation in a state compliant to GAMP 5 throughout the system's life cycle
  • Processes system change control, documents configuration, and writes test plans to ensure that the MES remains in a validated state
  • Liaise with Technical Trainers to develop training plans for MES users
  • Provides end-user support for the MES including troubleshooting problems on the floor and work closely with IT to troubleshoot problems
  • Implement strategies to improve process efficiencies


Knowledge and Skills:

  • Knowledge of BioPharma Manufacturing and Supply Chain Process
  • Knowledge and experience of MES preferably Werum PAS/X
  • In depth knowledge of concepts of GMP, ICH guidelines and GAMP requirements
  • An understanding of the project lifecycle and of quality management processes
  • Logical troubleshooting and problem solving skills
  • Excellent analytical, written and oral communication skills



Core Competencies:

BS/BA/BEng in a Technical Discipline required, with 0-2 years of experience working within a Life Sciences manufacturing environment.
Will substitute relevant industry experience in lieu of educational requirement

Interested?

Contact Dan on (01) 645 5250 or click "apply"

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