Senior MES Production Specialist

21 hours ago

Ballina, Mayo County, Ireland beBeeManufacturing Full time €85,500 - €98,700

We are seeking a seasoned Manufacturing Expert to join our team.

Maintain and optimize the manufacturing environment, create and update production recipes and worksheets for our site.

Provide technical guidance and support to other manufacturing experts. Act as a site escalation point for complex or challenging troubleshooting or recipe design. Provide project management expertise to our manufacturing function.

Main Responsibilities
  • Design, develop, write and/or make all required changes to manufacturing recipes, worksheets, equipment and material specifications including phase transition logic.
  • Design, develop, write and execute, test and validation protocols, risk assessments, and system documentation.
  • Ensure that cleaning, equipment and product procedures are aligned to manufacturing processes and vice versa.
  • Provide training for all other site personnel on their related manufacturing roles and arrange system access.
  • Liaise with our global manufacturing team to improve our manufacturing system.
  • Support other manufacturing system users to ensure business continuity.
  • Participate in new product introduction (NPI) projects from initiation to ensure our manufacturing system or hardware requirements are taken into consideration.
  • Document all activities in line with current Good Manufacturing Practices (cGMP) requirements.
Requirements
  • Bachelor's degree in 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.
  • Proficient with manufacturing 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.

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