Sanofi Manufacturing & Supply is shaping the future of biopharmaceutical manufacturing through Modulus, a transformational program that sits at the heart of Sanofi's strategy. Modulus introduces a new generation of modular, multi-product manufacturing facilities that are flexible, scalable, and digitally enabled, leveraging disruptive technologies to accelerate the production of vaccines and Specialty Care biologics.

As the Automation Engineer you will serve as the Site Subject Matter Expert (SME) for the plant historian platform, ensuring reliable, compliant, and high-performing data acquisition systems that support GMP manufacturing operations. You will play a key role in maintaining validated automation infrastructure, supporting digital transformation initiatives, and driving continuous improvements across the manufacturing site.

Key Responsibilities

Routine Operations

• Maintain and administer the site Historian system, ensuring high system availability, reliability, and GMP compliance to support manufacturing operations.

• Manage connectivity and data integration between the Historian and plant automation systems, including MES, DeltaV, SCADA, benchtop equipment, and other manufacturing systems.

• Monitor, optimize, and continuously improve system performance, data acquisition, and processing capabilities.

• Provide technical support and on-call assistance for critical Historian and data connectivity issues.

• Lead Computer System Validation (CSV) activities related to data connectivity, including preparation of validation documentation and execution of qualification testing.

• Perform routine maintenance activities to ensure systems remain in a validated state and fully compliant with GxP and Data Integrity requirements.

• Collaborate with Digital, Automation, and IT teams to troubleshoot system issues, improve automation performance, implement cybersecurity initiatives, and support routine patch management.

• Ensure system data storage and archival comply with corporate data retention policies and regulatory requirements.

• Manage alarms, periodic system reviews, and audit trail reviews to ensure ongoing Data Integrity compliance.

• Develop, maintain, and continuously improve automation system documentation and SOPs, including system operation, maintenance, backup and recovery, and user access management.

• Participate in the global Community of Practice (CoP) to review, harmonize, and enhance engineering and automation standards.

• Represent the Engineering function as the Historian System SME during internal and external audits.

• Manage automation system spare parts, vendor relationships, and supplier contracts related to assigned systems.

Project Support

• Serve as the Historian SME for Tier 3 projects (≤ €5 million), including new technology implementations, manufacturing improvements, and digital transformation initiatives.

• Perform automation assessments, system implementation, integration, and Computer System Validation (CSV) activities for assigned projects.

• Represent Manufacturing and Engineering during automation design reviews, providing technical input for key project deliverables such as:

  • User Requirements Specifications (URS)

  • System Impact Assessments (SIA)

  • Design Reviews (DR)

  • Design Qualification Reports (DQR)

• Ensure automation solutions comply with Sanofi engineering standards, GMP requirements, and business objectives.

Qualifications & Experience

• Bachelor's or Master's Degree in Engineering, preferably in Chemical Engineering, Electrical & Electronic Engineering, Instrumentation Engineering, Industrial Systems Engineering, Pharmaceutical Engineering, or a related discipline.

• Experience within the biopharmaceutical, biotechnology, pharmaceutical, or API manufacturing industry.

• Strong hands-on experience with AspenTech IP.21 Historian, including Batch Extractor and SQL+.

• Experience configuring and supporting industrial communication protocols and interfaces, including ODBC, OPC UA, OPC DA, and Profinet.

• Knowledge of manufacturing network infrastructure, virtualization platforms, and industrial cybersecurity principles.

• Experience performing Computer System Validation (CSV) activities within regulated GMP environments.

• Strong understanding of GxP compliance, Data Integrity principles, and pharmaceutical quality requirements.

• Proven ability to lead automation initiatives, coordinate external system integrators, and manage technical project deliverables.

• Strong technical writing skills, with experience developing SOPs, validation documentation, engineering specifications, and other GMP documentation.

• Excellent analytical, troubleshooting, and problem-solving skills, with the ability to communicate technical solutions effectively to cross-functional stakeholders.

• Experience with Manufacturing Execution Systems (MES) would be an advantage.

• Self-driven, collaborative, and proactive, with a continuous improvement mindset and the ability to work effectively in a fast-paced manufacturing environment.

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