Automation Engineer

SANOFI-AVENTIS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Sanofi-Aventis Singapore Pte. Ltd. is seeking an Automation Engineer (BMS & EMS) to join the Site Automation team in Singapore.

The role focuses on design, implementation, operation and lifecycle management of automation solutions with emphasis on BMS and EMS, ensuring compliance with cGMP, GAMP and cybersecurity standards while supporting CSV activities and continuous improvement. You will lead validation, documentation and project activities across FAT/SAT, start-up and collaborations with

Qualifications

• Experience with GxP automation systems and lifecycle management.
• Knowledge of cGMP, GAMP and regulatory requirements.
• Experience with CSV and validation activities.
• Cybersecurity controls for automation systems would be beneficial.

Responsibilities

• Design, implement and operate BMS/EMS automation solutions.
• Lead or support CSV activities during system lifecycle.
• Maintain documentation, specifications and validation records.
• Ensure data integrity and regulatory compliance across systems.
• Support audits, inspections and CAPA in automation.
• Collaborate with IT to implement cybersecurity controls.
• Oversee FAT/SAT and start-up activities for projects.
• Vendor management and technical evaluation for automation projects.

Job description

About the Job

The Project is at the cornerstone of our 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) 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.