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MES Engineer

Job description

Are you an MES Engineer with over 5 years' experience in an aseptic pharmaceutical environment?

Job responsibilities:

  • Development, configuration, and testing of Master Batch Records (MBRs) from initial to the final design.
  • Leading MBR development design reviews including liaising with Operations, Process Development, and Quality functions.
  • Drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.
  • Support and ongoing development of MES system in the development of MBRs and improving the MES business process.
  • Training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).
  • Development, review, and update of MES Standard Operating Procedures.
  • Preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner, etc.
  • Equipment integration design, configuration, and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - Siemens, Rockwell, Kepware OPC Server
  • Contribute to and assist with Corporate, FDA, IMB Auditors, and other regulatory bodies during company audits.

Job requirements:

  • 3rd level degree in Engineering or Science
  • Working knowledge of parenteral in pharmaceutical/biotech industries or aseptic processing
  • Knowledge of regulation requirements (GMP & EH&S)
  • 5+years of experience in an aseptic pharmaceutical environment.
  • Broad technical experience in MES systems.

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel at sigmar.ie

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