MES Engineer/Specialist

Overview Sanofi Manufacturing & Supply is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi's strategy, aiming to create a new generation of evolutive multi-product facilities that are modular, adaptable, and agile, while leveraging disruptive technologies to better address vaccine and biologics manufacturing challenges. The MES Specialist / MES Engineer is responsible for supporting the operation, monitoring, maintenance, and continuous improvement of the OpCenter Pharma Manufacturing Execution System (MES) within the Modulus Singapore facility. The role ensures the MES operates reliably and in compliance with GxP, data integrity, and validation requirements, supporting uninterrupted production execution and electronic batch record (EBR) workflows. Key Responsibilities MES Operations & Support • Support the day-to-day operation, monitoring, and maintenance of the OpCenter Pharma MES to ensure system availability, reliability, and performance. • Ensure the MES functions correctly for production execution and EBR workflows. • Participate in night call / after-hours support rotations, performing first-level troubleshooting and escalating complex issues as needed. • Own the MES platform end-to-end, including operations, administration, and configuration, with minimal supervision. • Prioritize MES incidents and keep the MES Manager and stakeholders informed of downtime and major incidents. PI Modeling & Master Data Management • Execute PI changes and master data updates in OpCenter Pharma, following established standards and change control procedures. • Maintain a well-structured master data environment by applying and enforcing naming conventions, hierarchies, and data governance rules. • Apply good PI modeling practices (modular, reusable, scalable), flagging and remediating suboptimal or legacy designs. Investigations, Deviations & Compliance • Support investigations into MES incidents and deviations, including data gathering, documentation, and root cause analysis. • Lead MES investigations where required, defining and implementing CAPA in line with GMP requirements. • Ensure compliance with GxP, data integrity, and validation requirements in all MES configuration and change activities. Cross-Functional Collaboration & Documentation • Collaborate with Manufacturing (MFG), Quality Assurance (QA), Smart Factory, and Digital teams to translate business requirements into robust MES solutions. • Advise MFG and QA on MES data, design, and system usage. • Contribute to and maintain technical documentation, including SOPs, work instructions, and design specifications, to support audit readiness. Core Competencies • Working knowledge of OpCenter Pharma or similar MES platforms, including configuration and administration. • Understanding of PI modeling concepts and manufacturing execution in a pharmaceutical setting. • Familiarity with GxP, data integrity, CSV/CSA, and change control principles. • Strong analytical and troubleshooting skills with a structured problem-solving approach. • Effective communication, teamwork, and sound escalation judgment. • SQL or scripting skills are a plus; knowledge of MES integration with SCADA, ERP, PLCs, or Smart Factory/IIoT platforms is an advantage. Technical & Educational Background • Bachelor's degree in Engineering, Pharmaceutical, Life Sciences, or a related field (or equivalent experience). • 1–10 years of experience supporting or administering an MES in a GMP-regulated pharmaceutical, biotech, or similar manufacturing environment. • Hands-on OpCenter Pharma experience. • Experience with master data and PI/process definitions within an MES or similar manufacturing IT system. • Experience in on-call