Sanofi is looking to optimize and advance its Manufacturing Execution System (MES), Data Historian, IIoT, and IT/OT Interfaces configuration systems to ensure seamless and efficient operations, maintain high performance, regulatory compliance, and operational efficiency in their manufacturing environment.
Requirements
- Experience in MES systems and managing teams.
- Expertise in MES systems preferably Siemens OpCenter Pharma execution.
- Strong knowledge in Master Batch Record and Review by Exception business processes and relevant solutions/modules/functionalities.
- In-depth knowledge of GMP, safety regulations, and other relevant compliance requirements in the pharmaceutical manufacturing environment.
- Strong analytical and troubleshooting abilities, with a focus on identifying and resolving operational issues quickly and efficiently.
- Experience in leading cross-functional teams and driving operational improvements.
- Ability to think strategically about MES systems and processes, balancing short-term operational needs with long-term business goals and technological advancements.
Responsibilities
- Oversee the daily operations of MES, Data Historian, IIoT and IT/OT systems.
- Develop and implement strategies for the ongoing optimization, integration, and modernization of MES systems in manufacturing.
- Ensure that MES systems are designed, updated, and operated to meet both current and future production needs.
- Oversee the daily monitoring, troubleshooting, and support of MES systems to ensure continuous production with minimal downtime and maximum efficiency.
- Identify, propose, and implement process and system improvements to enhance performance, reduce costs, and improve flexibility in manufacturing operations.
- Ensure that all activities comply with GMP, safety standards, and other relevant regulations.
- Oversee MES-related projects, from process improvements to the implementation of new technologies.
Other
- Lead and mentor a team of MES engineers/specialists/technicians, providing guidance and support.
- Work closely with engineering, production, quality, Digital (ITS), and other cross-functional teams to ensure alignment with production goals and regulatory requirements.
- Develop and implement training programs for staff on the proper operation, troubleshooting, and maintenance of MES systems.
- Foster a culture of continuous learning and knowledge sharing within the IMS team.
- Lead the coordination of external vendors and contractors in the implementation, maintenance, and support of changes for process improvement.
- Establish key performance indicators (KPIs) to track and improve the performance of the systems.
- Provide regular reporting on system performance, maintenance activities, and continuous improvement initiatives to senior leadership.