Large Scale mAbs Automation Lead

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

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