MES Engineer/Specialist

TheMES Engineer sits within theSite Engineering & Maintenance Department and is responsible for the implementation, maintenance, optimisation and lifecycle management of the siteManufacturing Execution System (MES) and associated integrations.

Acting as theBusiness System Owner (BSO) and technical SME for MES, the role ensures that the system remains reliable, compliant and fit for manufacturing needs while supporting system enhancements, IoT device integration, site projects and digitalisation initiatives.

Main Accountabilities

• Act as theBusiness System Owner (BSO) and SME for MES, leading system configuration, maintenance, upgrades and continuous improvement to support manufacturing requirements.
• Develop and maintainMES system architecture, databases, Process Instructions and technical specifications, ensuring alignment with global design standards and site requirements.
• Maintain and optimiseinterfaces and connectivity between MES and other site systems, including integration of relevant IoT devices and digital solutions.
• Provide advanced technical support, troubleshoot complex MES issues and collaborate closely with theDigital team and system vendors to ensure timely resolution and minimise system downtime.
• Lead the implementation of MES-related activities arising fromsite projects, change controls, deviations and CAPAs, providing technical expertise from design through commissioning and operational handover.
• Support theComputerised System Validation (CSV) lifecycle, including validation activities, system changes, documentation and maintenance of the validated state.
• Ensure MES remains compliant withGMP, data integrity, cybersecurity and applicable regulatory requirements, including appropriate user access, security controls, system backup and recovery processes.
• Serve as the MES SME duringregulatory inspections, internal audits and self-inspections, supporting documentation, investigations and remediation activities as required.
• Monitor system performance, downtime and deviations, identify recurring issues and drive improvements to enhancesystem reliability, operational efficiency and user experience.
• Develop and maintain relevantSOPs, technical documentation, system specifications and engineering records in accordance with site Quality and Engineering standards.
• Provide technical training and ongoing support tooperations and end users, ensuring appropriate understanding and use of MES functionalities.
• Manage MES system vendors fortechnical support, troubleshooting, maintenance and project execution, including review of technical proposals and vendor documentation.
• Participate inglobal MES and digital networks, sharing lessons learned and supporting global initiatives while ensuring alignment with global standards and design guidelines.

Key Decision / Advisory Responsibilities

The MES Engineer will have responsibility for determining appropriatesystem configurations and technical optimisation strategies, while providing expert advice on troubleshooting, system performance and technical solutions. The role will monitor and report MES downtime and deviations, contribute technical expertise throughout the validation lifecycle, and support compliance documentation, inspections and continuous improvement activities.

Key Interfaces

The role will work closely withManufacturing, Engineering & Maintenance, Digital/IT, Automation, Quality, Validation, Global MES teams and external system vendors to ensure reliable, compliant and effective operation of the site's MES environment.

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