Large Scale mAbs Automation Lead

Sanofi • Framingham, PA

2d • Onsite

About The Position

The Automation Lead will lead the automation workstream during the design, construction, and qualification of Sanofi’s new Large Scale mAbs facility. The role is the technical authority for automation and manufacturing control systems, from concept design through commercial readiness, and leads internal automation resources while managing external contractors. The position partners with Engineering, Validation, Manufacturing, Digital, MSAT, and Quality teams to deliver an integrated, GMP-compliant digital plant.

The role develops the manufacturing systems strategy, defines automation solutions and technical standards, and oversees system design, integration, testing, validation, cybersecurity, and data integrity. It also supports the facility’s integration into the existing brownfield site, workforce planning and training, system handover, and deployment of Sanofi’s IIoT and Smart Factory capabilities.

Requirements

• At least 8 years of automation engineering experience within the pharmaceutical industry is listed as a basic qualification, though the posting describes this experience as preferred.
• Bachelor’s degree in Engineering, Automation, Computer Science, Biotechnology, Pharmaceutical Sciences, or another field.
• Thorough knowledge of cGMP and regulatory requirements.
• Proficiency with Process Control Systems (DeltaV), Industrial Application Platform (Ignition), PLCs (Rockwell), and other automation technologies, including Data Historian, Building Management Systems (BMS), and Manufacturing Execution Systems (MES).
• Systems engineering mindset and ability to design and implement robust system integration architectures.
• Strong analytical and problem-solving skills.
• Effective communication with stakeholders and ability to lead and collaborate with cross-functional teams.
• Demonstrated ability to build high-performing teams.
• Ability to strive for results and make decisions in a complex, fast-paced environment.
• Excellent communication skills.
• Ability to influence and build strong relationships with internal and external partners.

Nice To Haves

• At least 3 years in a leadership or project lead role.
• A proven track record managing complex manufacturing systems involving automation, robotics, and advanced technologies.
• Experience in multi-site operations, global projects, and matrix management.
• Intercultural experience.

Responsibilities

• Develop and implement a manufacturing systems strategy for the Large Scale mAbs facility aligned with safety, quality, business, and user requirements.
• Serve as the automation subject matter expert during Basis of Design and detailed design phases.
• Select automation solutions and technical standards in accordance with Sanofi core solutions.
• Create project plans covering schedules, resource allocation, milestones, and deliverables for automation and manufacturing systems.
• Integrate automation systems with digital applications and connect production, quality control, and data management systems.
• Ensure compliance with Sanofi automation design standards, instrumentation specifications, and software conventions.
• Promote consistent automation design and execution across Sanofi facilities, applying network lessons learned to improve design, commissioning, and long-term operability.
• Coordinate with procurement and project teams to select vendors whose solutions meet quality and regulatory standards.
• Oversee external system integrators and collaborate with engineering partners, internal stakeholders, and project teams to meet timelines, budgets, and quality standards.
• Manage integration of process equipment vendor packages into the centralized DCS/MES.
• Lead code reviews, factory acceptance tests (FATs), and site acceptance tests (SATs) for automation software and hardware.
• Partner with CQV to execute automation validation strategies, review and approve protocols, resolve automation-related deviations, and manage change controls.
• Ensure safety and quality standards and regulatory commitments are met.
• Support integration of the new facility into the legacy brownfield site, including workforce planning, training, and system handover.
• Identify, monitor, and report project risks and implement mitigation plans.
• Lead deployment of Sanofi’s Next Generation IIoT Platform and ensure systems and equipment are integrated with standardized data models as specified by global Digital and M&S core teams.
• Champion Cyber by Design principles, including OT/ICS cybersecurity controls, network segmentation, and secure remote access.
• Design data integrity, traceability, and system resilience into system architectures, including secure-by-default configurations, patch management, backup and disaster recovery, and audit-trail integrity.
• Partner with Sanofi’s Smart Factory team to implement and integrate Factory of the Future process target pictures and align the facility’s automation architecture with Sanofi’s digital manufacturing vision.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employee benefit programs; additional benefits information is available through the company.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior