MES Engineer

2 weeks ago


Galway, Galway, Ireland TN Ireland Full time

Our client, a global healthcare company, is currently recruiting for an MES Engineer to join their growing team in Westport, Co. Mayo.

Responsibilities:
  • Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material specifications including phase transition logic.
  • Design, create, write and execute test and validation protocols, risk assessments, and system documentation.
  • Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
  • Provide training for all other site personnel on their related MES roles and arrange system access.
  • Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-arounds and fixes identified.
  • Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
  • Documentation of all activities in line with cGMP requirements.
Requirements:
  • Third Level qualification in manufacturing, engineering or business discipline.
  • A minimum of 2 years experience preferably using POMSnet.
  • Familiar with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
  • Experience of batch processing operations in an FDA/HPRA regulated industry.
  • Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
  • SAP knowledge/experience in MM, PP, and IM modules an advantage.
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