Operations Manager Mes

4 days ago

Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

Job Overview

Regeneron Ireland Dac seeks an experienced Operations Manager to oversee the implementation and day-to-day operation of its Manufacturing Execution System (MES). The ideal candidate will possess a strong understanding of MES systems, excellent analytical and problem-solving skills, and the ability to work effectively within a team.

The successful candidate will be responsible for ensuring that MES operations meet the needs of the business by aligning with Commercial Manufacturing requirements. Key responsibilities include implementing and running the MES system, coordinating with various functional groups to prioritize MES operations, and optimizing system installation to drive continuous process improvements.

  • Key Responsibilities:
  • Implementing and running Regeneron's MES system, ensuring alignment with site policies and processes.
  • Coordinating with various functional groups to prioritize MES operations.
  • Optimizing system installation and driving continuous process improvements.
  • Reviewing company documentation (SOPs, requirements, Manufacturing Batch Records) to assess MES impact.
  • Building strong business relationships with Commercial Manufacturing, Quality Assurance, and Material Management teams.
  • Collaborating with other IOPS sites to deliver the MES system.
  • Partnering with IT to meet MES Operations goals and objectives.
  • Working with Procurement and IT to establish good relationships with external vendors and suppliers.
  • Aligning MES practices with Commercial Manufacturing objectives to anticipate and address future needs.
  • Designing and maintaining MES Recipe Authoring, Workflows, Electronic Batch Records, etc.
  • Supporting User Acceptance Testing (UAT) for MES upgrades and changes.
  • Reviewing and approving MES Change Controls, ensuring GxP compliance.
  • Responding to audit inquiries.
  • Collaborating with Commercial Manufacturing and Technical Training to develop and schedule training sessions.
  • Providing guidance and support to MES Operations team members, ensuring they have the skills and tools needed for success.
  • Delivering performance and usage metrics to management and users.
  • Providing strategic updates to senior management.

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