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MES Engineer

1 month ago

Sligo, Sligo, Ireland Cpl Healthcare Full time

MES Engineer (Senior) – Westport

Key Responsibilities

  1. Maintain the MES (POMSnet) environment; to author and maintain recipes and worksheets for the Westport site.
  2. Provide technical guidance and solutioning to other MES Engineers.
  3. Act as site escalation point for complex or challenging troubleshooting or recipe design.
  4. Provide project management guidance and expertise to the MES function.
  5. Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material specifications including phase transition logic.
  6. Design, create, write and execute test and validation protocols, risk assessments, and system documentation.
  7. Ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
  8. Provide training for all other site personnel on their related MES roles and arrange system access.
  9. Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds and fixes identified.
  10. Liaise with Abbvie Global MES on Westport required system improvements.
  11. Provide support to other MES system users as required to ensure business continuity.
  12. Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
  13. Keep other recipe authors up to date on MES changes.
  14. Document all activities in line with cGMP requirements.
  15. Cross train within the team and train new team members.
  16. Participate in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
  17. Adhere to and support all EHS standards, procedures and policies.

Minimum Requirements

  1. Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
  2. A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects.
  3. Be proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
  4. Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
  5. A good knowledge of IT systems is required for this role.
  6. SAP knowledge/experience in MM, PP and IM modules.
  7. Proven attention to detail and mental concentration, to always ensure total compliance with procedures.
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