Large Scale mAbs Automation Lead

Sanofi; Framingham (MA); On-site; USD 149,000 - 215,000; Full time

Benefits offered by this job

Health benefits

Parental leave

Career growth opportunities

Job summary

Sanofi is seeking a Large Scale mAbs Automation Lead to drive automation strategy during design, construction, and qualification of a new facility in the US. You will act as the technical authority for automation and manufacturing control systems, leading internal teams and coordinating with external contractors to deliver a compliant digital plant.

You will partner with MSAT, Validation, Quality, and Digital teams to ensure scalable, secure, and data-integrated systems across production,

Qualifications

• 8+ years of automation engineering experience in the pharmaceutical industry.
• Bachelor's degree in Engineering, Automation, Computer Science, Biotechnology, Pharmaceutical Sciences, or a related field.
• Experience leading multi-site projects and matrix teams.

Responsibilities

• Develop and implement a strategy for manufacturing systems for the Large Scale mAbs facility, aligned with safety, quality, and user requirements.
• Serve as automation SME during basis of design and detailed design, selecting automation solutions and standards.
• Create detailed project plans with schedules, resources, milestones, and deliverables for automation and manufacturing systems.
• Integrate automation with digital applications, ensuring connectivity between production, quality, and data management.
• Ensure adherence to Sanofi automation design standards, instrumentation specs, and software conventions.
• Coordinate with procurement to select vendors meeting quality and regulatory standards.

Skills

Leadership

Project management

Cross-functional collaboration

cGMP knowledge

Cybersecurity

Regulatory compliance

Education

Bachelor's degree in Engineering or related field

Tools

DeltaV

Ignition

Rockwell PLCs

Data Historian

BMS

MES

Job description

Job Title: Large Scale mAbs Automation Lead

Location: Swiftwater, PA

About the Job:

The Automation Lead will lead the Automation workstream during the design, construction and qualification of the new Large Scale mAbs facility. The Automation lead serves as the technical authority for all automation and manufacturing control systems from concept design through to commercial readiness. The Automation Lead will lead internal automation resources, manage external contractors and partner closely with Engineering, Validation, Manufacturing, Digital, MSAT and Quality teams to deliver a fully integrated GMP-compliant digital plant.

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:

From project execution phase up to routine manufacturing, the responsibilities of the LSM Engineering Project include:

• Develop and implement a comprehensive strategy for manufacturing systems for the Large Scale mAbs facility ensuring alignment with safety, quality, business and user requirements.
• Serve as the automation subject matter expert (SME) during Basis of Design and detailed design phases. Decide on automation solutions and technical standards to be implemented in accordance with Sanofi core solutions.
• Create detailed project plans outlining schedules, resource allocation, milestones, and deliverables for the automation and manufacturing systems scope.
• Integrate automation systems with digital applications, ensuring seamless connectivity between production, quality control, and data management.
• Ensure the project adheres to all Sanofi automation design standards, instrumentation specifications and software conventions. Ensure consistency in automation design and execution between the Large Scale mAbs facility and all other Sanofi facilities, adhering to a uniform approach and leveraging lessons learned across the network to optimize design, commissioning, and long-term operability.
• Coordinate with procurement and project teams to select vendors, ensuring their solutions meet quality and regulatory standards.
• Oversee external system integrators and collaborate with engineering partners, internal stakeholders and the project team to ensure deliverables meet project timelines, budgets and quality standards,
• Manage the integration of integration of process equipment vendor packages into the centralised DCS/MES
• Lead code reviews, FATs and SATs for automation software and hardware.
• Partner with the CQV team to execute automation validation strategies, including the review and approval of protocols, resolution of automation related deviations and management of change controls.
• Ensuring all Safety & Quality Standards, as well as Regulatory commitments, are met with the highest standards of quality.
• Preparing and supporting proper integration of the new facility within the legacy brownfield site including strategic workforce planning and training and system handover.
• Ensuring project risks are properly identified, followed-up and reported, and that mitigation plans are implemented.
• Lead the deployment of Sanofi's Next Generation IIoT Platform within the Large Scale mAbs facility, ensuring all systems and equipment are integrated and standardized data models are deployed as specified by the global Digital and M&S core teams.
• Champion Cyber by Design principles throughout the automation lifecycle ensuring OT/ICS cybersecurity controls, network segmentation, and secure remote access are architected into the control system landscape from the outset rather than retrofitted.
• Ensure data integrity, traceability, and system resilience are designed into all system architectures from concept design, including secure-by-default configurations, patch management strategy, backup/disaster recovery planning, and audit-trail integrity for all automation and manufacturing control systems.
• Partner with Sanofi's Smart Factory team to implement and integrate the Factory of the Future process target pictures, ensuring the Large Scale mAbs facility automation architecture is aligned with Sanofi's digital manufacturing vision and positioned as a flagship intelligent, connected, and data-driven asset from day one of commercial operation.

About You:

Basic Qualifications:

• 8+ years' experience in automation engineering within the pharmaceutical industry preferred
• Bachelor's degree in Engineering, Automation, Computer Science, Biotechnology, Pharmaceutical Sciences, or a any field.

Preferred Qualifications:

• 3+ years in a leadership or project lead role.
• Proven track record in managing complex manufacturing systems involving automation, robotics, and advanced technologies.
• Experience in multi-site operations, global projects and matrix management.
• Thorough knowledge of cGMP and regulatory requirements.
• Proficiency in Process Control Systems (DeltaV), Industrial Application Platform (Ignition), PLCs (Rockwell), and other automation technologies (Data Historian, Building Management Systems (BMS) and Manufacturing Execution Systems (MES)).
• Systems engineering mindset with an ability to design and implement robust system integration architectures.
• Strong analytical and problem-solving skills, effective communication with stakeholders, and leadership and collaboration abilities with cross-functional teams.
• Demonstrated ability to build highly performing teams.
• Strive for results and ability to make decisions in a complex and high-speed environment
• Intercultural experience
• Excellent communication skills
• Ability to influence and build strong relationships with internal and external partners.

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 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 affirmative 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.

Sanofi US endeavours to make our career center accessible to any and all users.

US and Puerto Rico Residents Only

North America 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.

The salary range for this position is:

$148,500.00 - $214,500.00

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.