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.
Experience
About You
- 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.
