The Role:

ElevateBio is seeking an Automation Engineer II to play a key role in owning the BaseCamp facilities controls and automation systems. This role develops support models to ensure reliable operations, manages vendor and software support contracts, and provides technical support for manufacturing, quality, and research automated systems. The Automation Engineer II supports capital projects and facility expansions, ensures new assets are integrated into the automation infrastructure, troubleshoots manufacturing equipment, and partners closely with Quality and Validation to ensure compliance and system readiness.

Success in this role requires strong system ownership, collaboration, and a customer focused mindset. The ideal candidate brings strong technical expertise in facility controls and infrastructure such as BMS, BAS, BacNet, and MTPS; automation systems including SCADA, PLCs, HMIs, and data historians; and regulatory requirements such as 21 CFR Part 11, Annex 11, and data integrity. A passion for learning, attention to detail, and hands on problem solving are essential. Robust, lean automation and data collection are critical to supporting ElevateBio’s strategy to rapidly launch next generation cell and gene therapies for patients.

Here’s What You’ll Do:

• Manage control and automation systems projects through the entire project life cycle and ensure that systems are maintained in compliance state after go live.
• Work hand in hand with Facilities, Engineering, MSAT and Operations teams to support their projects and operational needs
• Troubleshoot issues with facilities control systems, automation systems or related infrastructure to ensure and improve manufacturing performance (e.g. yield improvements, etc.) while maintaining all those systems in compliance with cGMPs.
• Provide configuration, development, and break/fix day-to-day support of automation systems.
• Manage automation system documentation and SOPs, prepare technical and user documentation, and conduct system training
• Lead automation-related investigations into Quality Event Reports and implement the necessary corrective actions.
• Lead system maintenance and manage automation life cycle (review application patching, document test plans, and execute test scripts)
• Coordinate with business users for development of reports (batch, material, audit trails, etc.) to support efficient operations.
• Manage automation contractors supporting projects, day-to-day systems operations, planned and unplanned maintenance activities and ensure they comply with safety and quality systems.

Requirements:

• Bachelor’s degree in Engineering, Science, or related technological field
• 6+ years’ experience in life-science regulated environment (e.g. FDA) with working knowledge of the regulatory requirements for pharmaceutical applications
• 4+ years’ experience integrating/interfacing equipment to control systems via OPC, Ethernet IP, etc.
• Experience with PLCs (e.g. Allen Bradley & Siemens), SCADA (e.g. Ignition), Batch Operations (S88/S95), OSI Soft Pi Historian, BMS/BAS (e.g. Siemens Desigo)
• Control panel and automation hardware and infrastructure design experience
• Demonstrated knowledge of 21CFR Part 11, Annex 11, and GAMP5
• Requires working in an pharmaceutical industrial manufacturing environment including gowning, desired with experience in aseptic operations.