The Role:

ElevateBio is seeking an experienced Facilities Technician II to join the team. The successful candidate will be detailed oriented, organized, and have a strong desire to learn. Key responsibilities will be performing or overseeing vendor performed maintenance/calibrations on GMP Utility systems, process equipment and clean room infrastructure in a highly regulated cGMP environment. The candidate must be willing to support on-call rotation and support additional shift coverage as needed including annual shutdown support. The shift coverage for this role is Wednesday-Saturday.

Here’s What You’ll Do:

• Utilizes CMMS to manage the completion of all maintenance assignments.
• Comply with Good Manufacturing Practices (GMP) requirements to include detailed documentation of work performed in both electronic and written form.
• Reports any maintenance failure or issues immediately to management.
• Evaluates equipment performance and makes recommendations to maintenance performance or system design.
• Seeks to continuously improve maintenance practices.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications to plan and perform maintenance and repair activities.
• Provides support during annual shutdowns.
• Routine performance of preventative maintenance on process support systems and equipment including but not limited to: Pumps, Valves, Autoclaves, Centrifuges, Reactors, BSC's, Isolators, WFI Generation/Distribution, Clean Steam, compressed gases, HVAC equipment
• Conducts rounds of GMP and non-GMP equipment and systems.
• Inspect, operate, or test machinery or equipment to diagnose machine malfunctions.
• Perform routine maintenance, such as inspecting drives, motors, or belts, checking fluid levels, replacing filters, or doing other preventive maintenance actions.
• Diagnose mechanical problems and determine how to correct them, checking blueprints, repair manuals, or parts catalogs, as necessary.
• Repair machines, equipment, or structures, using tools such as hammers, hoists, saws, drills, wrenches, or equipment such as precision measuring instruments or electrical or electronic testing devices.
• Maintain or repair specialized equipment or machinery located in cafeterias, laundries, hospitals, stores, offices, or factories.
• Assemble, install, or repair wiring, electrical or electronic components, pipe systems, plumbing, machinery, or equipment.
• Maintains all spaces clean and orderly.
• Coordinating and escorting contractors and vendors for the performance of preventative maintenance and repairs on process support systems.
• Supports quality systems for CAPA, Deviations and Change Management. Dismantle machines, equipment, or devices to access and remove defective parts, using hoists, cranes, hand tools, or power tools.
• Support Annual Shutdown, On-Call rotation and shift coverage.
• Commitment to perform all work in a safe manner. The ability and desire to excel in a fast paced, inclusive team environment which prides itself on providing the highest level of service to our internal customers. Desire to interact in a professional, helpful manner with staff at all levels within the organization on a regular basis.

Requirements:

• High School diploma, GED, or equivalent required
• Trade school or undergraduate education is preferred
• Professionally Licensed in any of the following areas desirable: Wastewater Treatment, Plumbing, Electrical, Refrigeration.
• 1 + years of applicable experience in a GMP environment is preferred
• Ability to multitask and always maintain professionalism
• Proficient in Microsoft Office products (Outlook, Word, Excel, etc.)
• Experience working with Blue Mountain RAM or other CMMS programs preferred
• Experience with DeltaV PCS System or other control system is a plus
• Ability to read, understand, and follow SOP, P&ID's and work instructions.
• Strong communication skills in both oral and written reports

The budgeted range for this position is $48.08 - $62.50. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. 

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.