Senior MES Engineer

4 weeks ago

Galway, Galway, Ireland Team Horizon Full time

Team Horizon is seeking a Senior 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 (POMSnet) environment; to author and maintain recipes and worksheets and provide technical guidance and solutions to the other MES Engineers. The MES Engineer will also act as the site escalation point for complex or challenging troubleshooting or recipe design, as well as provide project management guidance and expertise to the MES function.

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 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.
  • 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 site's 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.
  • Document all activities in line with cGMP requirements.
  • Cross-train within the team and train new team members.
  • Participate in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
  • Adhere to and support all EHS standards, procedures and policies.

What you need to apply:

  • Third level qualification in a suitable manufacturing, engineering or business course and/or suitable experience.
  • A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects.
  • Be proficient 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.
  • SAP knowledge/experience in MM, PP and IM modules.
  • Proven attention to detail and mental concentration, to always ensure total compliance with procedures.
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