Manufacturing System Lead

3 days ago


Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

Job Overview:

This role focuses on leading the deployment and support of Manufacturing Execution Systems (MES), ensuring seamless integration with Manufacturing Batch Records (MBRs) and Generic Manufacturing Batch Records (GMBRs). The successful candidate will oversee the coordination of team members, facilitate plant testing, and guarantee documentation readiness.

Key Responsibilities:

  • Review and approve MES project deliverables against the overall project plan
  • Populate and complete review of MES documentation, including Config Spec (MESCS) and Trace Matrices (TMs)
  • Lead Pre-PE executions and testing of MES records, ensuring compliance with GDP and regulatory requirements
  • Coordinate team efforts for documentation approval and data review for build of OPM recipes to support MES deployment
  • Maintain MES deployment support, facilitating documentation readiness and change control support
  • Ensure Process Area readiness for MES deployment, working closely with area owners
  • Sustain deployed MES records, guaranteeing timely close-out of executed MES records

Requirements:

  • Demonstrated knowledge and experience with MES systems, preferably Werum PAS/X
  • Strong analytical, written, and oral communication skills
  • Ability to work within a successful team, fostering collaboration and problem-solving
  • Bachelor's degree in a technical discipline, with 0-2 years of experience in Life Sciences manufacturing or equivalent combination of education and experience


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