Integrated Manufacturing Systems Manager

BioSpace; Framingham (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Sanofi Inc. in Framingham, MA seeks an experienced Automation and MES leader to develop and execute the site MES master plan, lead the MES and DHS team, and align resources with production schedules.

You will ensure compliance with FDA/EU regulations, drive improvements across MES platforms, and coordinate global initiatives. The role requires deep expertise in regulatory systems, data historian tools, and cross-functional collaboration across manufacturing, IT, and quality teams.

Qualifications

• Bachelor's degree in engineering or related field.
• Minimum 8–10 years in manufacturing automation or MES in regulated environments.
• 3–5 years in leadership managing technical teams.
• Experience leading strategy and roadmaps for MES projects.

Responsibilities

• Develop and execute the site MES master plan.
• Provide leadership and development of the MES and DHS team.
• Manage site MES resource plan and project prioritization.
• Ensure compliance with industry standards and regulatory requirements.
• Monitor MES/DHS operations to support production schedules.
• Troubleshoot issues to minimize downtime and maintain data integrity.

Skills

Leadership

Strategy development

Project delivery

Cross-functional collaboration

Digital transformation

Cybersecurity (OT/IT)

Education

Bachelor's degree in Engineering

Tools

Siemens MES

Rockwell PLC

Emerson DeltaV

Kepware

Data Historian

Job description

About The Job

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.

Job Title

• Location: Framingham, MA

About Sanofi

We are an R&D-driven, AI-powered biopharma company committed to improving peoples 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.

Main 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

• D: Strategy and Roadmap for site MES
• D: Decide on immediate troubleshooting steps and corrective actions for minor issues
• D/A: MES project prioritization and resource allocation
• D/A: Process improvement initiatives through MES
• A: Compliance strategies for MES
• A: Ensure data accuracy and integrity in data management tasks
• A/I: Assist with troubleshooting and ensuring smooth interface operations
• I: Involved in reporting system issues or trends to managers for strategic decisions
• I: Contribute to configuration processes, reporting any issues

About You

Basic Qualifications

• Bachelors 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
• I: Involved in record-keeping and data capture, ensuring documentation aligns with compliance standards

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affidective Acting employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.