MES Engineer/Specialist

Sanofi Aventis Singapore Pte. Ltd; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

Sanofi Aventis Singapore Pte. Ltd. is seeking an MES Engineer within the Site Engineering & Maintenance Department to implement, maintain, and optimise the Manufacturing Execution System and its integrations.

The role acts as the Business System Owner and technical SME for MES, ensuring reliability, compliance and support for site projects, digitalisation initiatives and regulatory requirements. You will collaborate with Digital/IT, Quality, Validation and external vendors to deliver

Qualifications

• Experience with MES systems and manufacturing IT.
• Knowledge of GMP, data integrity and regulatory requirements.

Responsibilities

• Lead MES system configuration, maintenance, upgrades and continuous improvement.
• Develop and maintain MES architecture, databases and specifications.
• Maintain interfaces and connectivity between MES and other site systems including IoT integration.
• Provide advanced technical support and collaborate with Digital IT and vendors to minimize downtime.
• Lead MES activities from site projects, change controls, deviations and CAPAs.
• Support CSV lifecycle, validation activities and documentation.
• Ensure MES compliance with GMP, data integrity and cybersecurity.
• Serve as MES SME during inspections and audits.
• Monitor performance, downtime and deviations; drive improvements.
• Develop SOPs and engineering records; provide training to operations and end users.
• Manage MES vendors for support and project execution.
• Participate in global MES and digital networks.

Job description

The MES Engineer sits within the Site Engineering & Maintenance Department and is responsible for the implementation, maintenance, optimisation and lifecycle management of the site Manufacturing Execution System (MES) and associated integrations.

Acting as the Business 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 the Business System Owner (BSO) and SME for MES, leading system configuration, maintenance, upgrades and continuous improvement to support manufacturing requirements.
• Develop and maintain MES system architecture, databases, Process Instructions and technical specifications, ensuring alignment with global design standards and site requirements.
• Maintain and optimise interfaces 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 the Digital team and system vendors to ensure timely resolution and minimise system downtime.
• Lead the implementation of MES-related activities arising from site projects, change controls, deviations and CAPAs, providing technical expertise from design through commissioning and operational handover.
• Support the Computerised System Validation (CSV) lifecycle, including validation activities, system changes, documentation and maintenance of the validated state.
• Ensure MES remains compliant with GMP, data integrity, cybersecurity and applicable regulatory requirements, including appropriate user access, security controls, system backup and recovery processes.
• Serve as the MES SME during regulatory 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 enhance system reliability, operational efficiency and user experience.
• Develop and maintain relevant SOPs, technical documentation, system specifications and engineering records in accordance with site Quality and Engineering standards.
• Provide technical training and ongoing support to operations and end users, ensuring appropriate understanding and use of MES functionalities.
• Manage MES system vendors for technical support, troubleshooting, maintenance and project execution, including review of technical proposals and vendor documentation.
• Participate in global 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 appropriate system 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 with Manufacturing, 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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