Automation Engineer
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.