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MES Engineer

Mayo, Mayo County
20 hours ago
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MES Engineer II

Team Horizon is seeking a MES Engineer for our client who are a global leader in the biopharmaceutical industry for their Mayo site.

The purpose of this role is to maintain the MES environment; to author and maintain recipes & worksheets. As well as troubleshooting ad providing solutions for MES and SAP problems in recipe execution and recipe authoring.

Why you should apply:

  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.

  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

  • Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

    What you will be doing:

  • Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's 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.

  • Design, create, write and 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.

  • Liaise with the Global MES on the sites required system improvements.

  • Provide support to other MES system users as required to ensure business continuity.

  • Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.

  • Keep other recipe authors up to date on MES changes

  • Documentation of all activities in line with cGMP requirements.

  • Cross training within the team and training of new team members.

  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.

  • Adheres to and supports all EHS standards, procedures and policies.

    What you need to apply:

  • Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.

  • A minimum of 2 years authoring experience preferably using POMSnet.

  • Be 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.

  • A good knowledge of IT systems is required for this role

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