Engineer II, Automation

 

The Role:

ElevateBio is looking for an Automation Engineer II who will play a key role in owning the Basecamp facilities controls and automation systems [Systems].  For these Systems, this role will develop support models to ensure robust operations, manage vendor and software support contracts, provide key support for various manufacturing, quality and research automated systems, supports capital projects for facility expansion, ensures new assets are integrated to the automation infrastructure, troubleshoots and support manufacturing operations equipment, and works closely with the Quality and Validation teams to ensure compliance and the systems are ready for use.  The Automation Engineer II will be successful in their responsibilities by owning the Systems and being a team player who thrives off delivering value to the customer.  This person should have a strong technical knowledge and experience in a variety of facility controls & infrastructure (e.g. BMS, BAS, BacNet, MTPS), automation systems & infrastructure (e.g. SCADA, PLCs, HMIs, Data Historian, etc.), regulatory requirements (e.g. 21CFR Part 11, Annex 11, Data Integrity, etc.), have a love of learning, and not be afraid to get into the details and execute to solve problems.  The robust, lean automation and data collection for our processes is critical to achieving ElevateBio’s strategy for quickly launching 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.