- Reference: GY44224
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
Responsible for the implementation and day to day operation of the Manufacturing Execution System, the integrity of the data within the system and those provided by the associated data exchanges. Responsible for ensuring that MES operations fully meets the needs of the business by aligning with Commercial Manufacturing requirements.
- Ensure that MES system installation aligns with site policies and processes.
- Coordinate the needs of functional groups across the site and establishes the priorities for MES operations.
- Strive for the optimum installation of the system and its continuous process improvement thereafter.
- Review company documentation including SOPs, requirements and Manufacturing Batch Records to assess MES impact.
- Develop strong business relationships with Commercial Manufacturing, Quality Assurance and Material Management groups to attain a solid understanding of their goals and objectives to ensure alignment with MES operations.
- Collaborate with other IOPS sites on the delivery of the MES system.
- Develop a strong business relationship with Information Technology to ensure that MES Operations goals and objectives are met.
- Collaborate with Procurement and IT to build strong working relationships with external vendors and suppliers.
- Align MES business practices with Commercial Manufacturing objectives to anticipate future needs and create solutions to address them.
- Ensure that MES Recipe Authoring, Workflows, Electronic Batch Records, etc. are developed and maintained to enable MES operations.
- Manage and develop MES Operations Analysts.
- Provide MES Operations support for User Acceptance Testing (UAT) for upgrades and other changes to MES.
- Review and approves MES Change Controls.
- Ensure GxP compliance.
- Respond to audit inquiries.
- Collaborate with Commercial Manufacturing and Technical Training to develop and schedule training sessions that best serve the business needs.
- Provide MES Operations team members with guidance and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals.
- Provide performance and usage metrics to management and users as required.
- Deliver strategic updates to senior management as required.
Skills, Experience and Qualifications:
- BA/BS in engineering, biological or physical science, computer science, or information technology required, and a minimum of 7 years of experience working with MES or manufacturing systems within a life science manufacturing environment.
- Previous supervisory experience required.
- Previous experience implementing MES preferred
For a confidential discussion and more information on the role/company please email your CV to: email@example.com