Integrated Manufacturing Systems Manager
Location: Framingham, MA
About the role
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.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.
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 lead 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 oversight 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 for understanding current global design guidelines and application.
Decision-Making Involvement
- Decide: Strategy and Roadmap for site MES.
- Decide: Immediate troubleshooting steps and corrective actions for minor issues.
- Decide/Approve: MES project prioritization and resource allocation.
- Decide/Approve: Process improvement initiatives through MES.
- Approve: Compliance strategies for MES.
- Approve: Ensure data accuracy and integrity in data management tasks.
- Assist/Involve: Troubleshooting and ensuring smooth interface operations.
- Involve: Reporting system issues or trends to managers for strategic decisions.
- Involve: Contribute to configuration processes, reporting any issues.
- Involve: Record-keeping and data capture, ensuring documentation aligns with compliance standards.
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).
- Professional certifications in MES platforms (e.g., Siemens, Rockwell, Emerson DeltaV), Project Management (PMP), SAP, or Industry 4.0/Smart Manufacturing.
- 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.
Benefits
- Supportive, future-focused team with endless opportunities to grow your talent and drive your career, whether through promotion or lateral move, at home or internationally.
- Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Opportunity to shape the future of medicine and vaccine delivery with cutting-edge technology.
- Leverage digital, data, and AI-driven innovation to power industry-leading performance.
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.