Senior Manufacturing Systems Specialist

3 days ago

Galway, Galway, Ireland beBeeManufacturing Full time €75,100 - €104,110
Job Overview

We are seeking a highly skilled Senior Manufacturing Systems Specialist to join our team. The successful candidate will be responsible for the maintenance of our Manufacturing Execution System (MES) environment, authoring and maintaining recipes and worksheets for our manufacturing site using the POMSnet system.

This role requires technical guidance and solutioning to other MES Engineers and acting as a site escalation point for complex or challenging troubleshooting or recipe design.

Key Responsibilities
  • Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material specs including phase transition logic.
  • Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
  • 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.
  • Support 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.
Requirements
  • A minimum of 5 years authoring experience using POMSnet.
  • Proven leadership skills, having led or been a technical lead on key implementation projects.
  • High proficiency 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.
  • Good knowledge of IT systems is required for this role.
  • SAP knowledge/experience in MM, PP and IM modules is a requirement.
Person Requirements

Candidates must have a B.Sc. Degree in Engineering or equivalent, with emphasis in software development, electrical, electronic or automation discipline, with a minimum of 3 years' experience in industry, preferably in a pharmaceutical, biotechnology, blue chip or relevant GMP manufacturing environment.

Excellent communication & problem solving skills, as well as strong stakeholder & vendor management skills, are essential.

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