Automation Engineer II

Elevate Bio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

Elevate Bio is seeking an Automation Engineer II to play a key role in owning the Base Camp 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, Bac Net, 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 Elevate Bio'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 21

CFR Part 11, Annex 11, and GAMP5
Requires working in an pharmaceutical industrial manufacturing environment including gowning, desired with experience in aseptic operations.

Why Join Elevate Bio?
Elevate Bio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The Elevate Bio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation,…