Automation Engineer

About the company

_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.

Your tasks

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.