About the Job
Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi's strategy, creating a new generation of evolutive, multi-product manufacturing facilities that are modular, adaptable and agile, leveraging disruptive technologies to better address vaccine and Specialty Care Biologics manufacturing needs.
As an Automation Engineer (BMS & EMS) – Modulus, you will be a key member of the Site Automation team, responsible for the design, implementation, operation and lifecycle management of automation solutions, with a primary focus on the site's Building Management System (BMS) and Environmental Monitoring System (EMS).
Ensuring quality, compliance and cybersecurity
- Ensure GxP automation systems are designed, operated and maintained in accordance with cGMP, GAMP and applicable regulatory requirements.
- Execute and support Computer System Validation (CSV) activities for routine system lifecycle activities and automation projects.
- Maintain appropriate automation documentation, system specifications, validation records and compliance documentation throughout the system lifecycle.
- Ensure data integrity requirements are maintained across GxP automation systems.
- Support regulatory inspections, internal audits and self-inspections as the Automation Subject Matter Expert (SME).
- Lead or participate in deviation investigations, root-cause analysis and CAPA implementation relating to automation systems.
- Collaborate with Digital/IT teams to implement appropriate cybersecurity controls, system access management, backup and recovery processes.
- Ensure automation systems remain compliant with applicable engineering, quality, cybersecurity and data-integrity standards.
Supporting automation projects and site start-up
- Manage assigned automation projects and deliver automation scope in accordance with site objectives, project timelines, quality requirements and global design standards.
- Provide technical expertise throughout the automation project lifecycle, from design and specification through installation, commissioning, qualification and handover.
- Develop, review and maintain automation technical specifications, system architecture and project documentation.
- Participate in and support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
- Support the start-up and automation of black utilities, HVAC and associated facility systems.
- Review global automation design guidelines and ensure appropriate application within site projects.
- Identify technical risks, resource requirements and dependencies, escalating where appropriate to support successful project execution.
- Participate in global automation and engineering initiatives when required.
Driving continuous improvement and system performance
- Identify opportunities to improve automation system reliability, performance, maintainability and operational efficiency.
- Support continuous improvement initiatives through automation, digitalization and data-driven solutions.
- Analyse recurring system issues and contribute to structured root-cause analysis and sustainable corrective actions.
- Optimize automation systems and control strategies to support efficient plant operations.
- Recommend and implement system improvements and upgrades in alignment with site and global automation strategies.
Managing documentation, vendors and technical capability
- Develop, maintain and update automation technical specifications, SOPs and system lifecycle documentation.
- Ensure documentation remains aligned with engineering, quality and regulatory standards.
- Manage automation system vendors and contractors supporting troubleshooting, maintenance, system upgrades and project execution.
- Review vendor technical proposals, system designs and documentation.
- Support RFQ, tender review, technical evaluation and vendor selection for automation projects.
- Provide technical training and knowledge transfer to Operations and relevant site personnel.
- Maintain awareness of emerging automation, digital manufacturing and control-system technologies.
About You
Experience
- Bachelor's degree in Automation, Control, Electrical, Electronic, Chemical Engineering, or a related engineering discipline.
- Typically 3–5 years of relevant automation experience, preferably within pharmaceutical, biopharmaceutical, vaccines, API or another highly regulated manufacturing environment.
- Hands-on experience with Building Management Systems (BMS), preferably Schneider Electric platforms, and Environmental Monitoring Systems (EMS).
- Experience supporting automation within greenfield and/or brownfield manufacturing projects.
- Experience with the start-up, commissioning or operation of HVAC and black utility systems.
- Practical experience supporting pharmaceutical plant engineering and automation systems within a cGMP environment.
- Experience participating in regulatory inspections or audits such as FDA, EMA and HSA would be advantageous.
Technical & Functional Skills
- Strong understanding of automation and control-system architecture, including PLCs, BMS, EMS, HMI and data historians.
- Knowledge of industrial communication protocols and networks, including Modbus TCP/IP, BACnet IP, BACnet MSTP, IO-Link and OPC UA.
- Knowledge of GAMP software development lifecycle and relevant automation standards, including ANSI/ISA-88 and ISA-95.
- Good understanding of Computer System Validation (CSV), data integrity and GxP automation system lifecycle management.
- Understanding of OT/IT integration and industrial cybersecurity principles, including system access controls, backup and recovery.
- Knowledge of HVAC control principles, cleanroom design requirements and pharmaceutical facility automation.
- Ability to interpret electrical symbols, schematic diagrams and automation/control drawings.
- Good understanding of current Good Manufacturing Practices (cGMP) and applicable pharmaceutical regulatory requirements.
- Knowledge of Singapore statutory and regulatory requirements and relevant codes of practice for process-industry projects would be advantageous.
- Experience in project procurement activities, including vendor and subcontractor management, RFQs, tender reviews and technical/commercial bid evaluation.
- Strong project planning, scheduling, documentation and reporting capabilities.
- Strong troubleshooting, analytical and structured problem-solving skills.
- Good communication and stakeholder-management skills, with the ability to collaborate effectively across Engineering, Manufacturing, Quality, Digital/IT and external partners.
- Ability to coordinate and provide technical direction to contractors, vendors and other external resources.
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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!