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Details

MES Operations Analyst


Reference:PORA005800 Location: Limerick
Qualification:DegreeExperience:1-2 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: IT Analyst

An MES Operations Analyst is required to join a leading international Biopharmaceuticals organisation in Limerick. 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

The Role

  • 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


The Person

  • BS/BA/BEng in a Technical Discipline required, with 0-2 years of experience working within a Life Sciences manufacturing environment.
  • 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






If you would like further Information you can contact the recruiter directly:



Paula O'Reilly | Tel: +353 (0) 1 507 9265