Integrated Manufacturing Systems Manager

Biopharma Careers; United States; On-site; USD 113,000 - 164,000; Full time

Benefits offered by this job

Health insurance

Job summary

Sanofi in Framingham, MA, is seeking a senior leader for the MES and DHS domain to drive the site MES master plan and oversee cross-functional teams responsible for production scheduling, data integrity, and regulatory compliance.

The role focuses on strategy development, system integration, and continuous improvement of automation platforms, ensuring GMP adherence and seamless global interfaces.

Qualifications

• Bachelor’s degree in engineering or related discipline.
• Minimum 8 years of progressive experience in manufacturing automation in a regulated environment.
• Experience leading MES strategy, roadmap development, and cross-functional project delivery.
• Knowledge of CSV and regulatory compliance (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).

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 and recruit for MES.
• Perform routine checks and monitor MES/DHS to support production schedules.
• Lead interface management to maintain MES and equipment integration.
• Ensure compliance with industry standards and regulations.
• Optimize production processes through MES implementations.
• Maintain documentation and records in compliance with regulatory standards.

Job description

Location:

Framingham, MA

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.

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.

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

• Bachelor’s degree in engineering (Chemical, Electrical, Computer, Industrial, or related discipline), Biotechnology, Computer Science, or any field
• Minimum 8 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)

Preferred Qualifications

• Minimum 3 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 it’s 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 andwellness 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 andAffirmative Action 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.

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

NorthAmerica Applicants Only

Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Salary range for this position is:

$113,250.00 - $163,583.33

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.