Integrated Manufacturing Systems Manager

Sanofi•Framingham, MA

2d•Onsite

About The Position

The Automation and Manufacturing Systems (AMS) group is at the forefront of Sanofi's digital transformation journey, driving operational excellence through innovative technology solutions and smart manufacturing initiatives. As a critical enabler of our global manufacturing network, the team drives the development, implementation, support and maintenance of leading automation strategies, Industry 4.0 technologies, and integrated automation manufacturing systems that enhance production efficiency, ensure product quality, and maintain computerized system regulatory compliance. Working closely with cross-functional partners at the site and global level, the group champions continuous improvement, ensures cybersecurity, and system robustness while fostering a culture of innovation that directly contributes to our mission of delivering life-changing medicines to patients worldwide. Through strategic leadership in automation, digital integration, and manufacturing excellence, the team plays a pivotal role in shaping Sanofi's future manufacturing capabilities and maintaining our competitive edge in the pharmaceutical industry. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Requirements

Bachelor's degree in engineering (Chemical, Electrical, Computer, Industrial, or related discipline), Biotechnology, Computer Science, or related technical field
Minimum 8-10 years of progressive experience in manufacturing, automation, MES implementation, or manufacturing systems engineering within a regulated industry (pharmaceutical, biotech, medical device, or similar GxP environment)
Minimum 3-5 years in a leadership or supervisory role managing technical teams
Demonstrated experience leading strategy, roadmap development, and cross-functional project delivery
Experience in computerized system validation (CSV) and regulatory compliance (FDA 21 CFR Part 11, EU Annex 11, GAMP 5)
10-12+ years of total experience in pharmaceutical manufacturing automation
Experience working in global or multi-site manufacturing environments
Direct experience with Sanofi's standard MES platforms and data historian systems
Track record of leading digital transformation or Industry 4.0 initiatives
Experience with cybersecurity frameworks for OT/IT systems
Involved in record-keeping and data capture, ensuring documentation aligns with compliance standards

Nice To Haves

Professional certifications in MES platforms (e.g., Siemens, Rockwell, Emerson DeltaV), Project Management (PMP), SAP, or Industry 4.0/Smart Manufacturing

Responsibilities

Develop and execute the site MES master plan.
Provide leadership and development of the MES and DHS team.
Develop and manage the site MES resource plan.
Allocate resources to projects, and leads MES recruitment
Perform routine checks and monitor MES and DHS to ensure smooth operation and support of production schedules
Lead and support interface management to maintain MES and equipment integration
Lead and provide oversite for configuration of MES, Data Historian, and Kepware systems
Ensure compliance with industry standards and regulations
Optimize production processes through MES implementations.
Follow established protocols to verify data completeness, accuracy, and compliance within MES/DHS
Troubleshoot system issues to minimize downtime and maintain operational efficiency
Maintain documentation and records in accordance with compliance standards
Participate in global networks, contribute lessons learned to the network
Participate in global initiatives when requested
Responsible to understand current global design guidelines and application
Key Involvement in Decision-Making Process: Strategy and Roadmap for site MES
Key Involvement in Decision-Making Process: Decide on immediate troubleshooting steps and corrective actions for minor issues
Key Involvement in Decision-Making Process: MES project prioritization and resource allocation
Key Involvement in Decision-Making Process: Process improvement initiatives through MES
Key Involvement in Decision-Making Process: Compliance strategies for MES
Key Involvement in Decision-Making Process: Ensure data accuracy and integrity in data management tasks
Key Involvement in Decision-Making Process: Assist with troubleshooting and ensuring smooth interface operations
Key Involvement in Decision-Making Process: Involved in reporting system issues or trends to managers for strategic decisions
Key Involvement in Decision-Making Process: Contribute to configuration processes, reporting any issues