About the role
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role
ElevateBio is looking for a Engineer I, Automation, who will play a key role in owning the site’s automation systems. For these automation systems, this role will designs, programs, and troubleshoots automated equipment and control systems under the supervision of senior automation engineers, supports managing vendor and software support contracts, includes procuring new equipment, defining specifications, unit testing, and implementation, and works closely with the Quality and Validation teams to ensure these systems are ready for use. The Engineer I, Automation will be successful in their responsibilities by owning the automation systems and being a team player who thrives off delivering value to the customer. This person possesses good technical understanding in a variety of automation and control systems, has a love of learning, and is not 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
- Support critical automation projects through the entire project life cycle and ensure that systems are maintained in a validated state after go-live
- Work hand in hand with Facilities, Engineering, and Operations teams to support their projects and operational needs
- Follow design standards for our automation platforms (SCADA/Ignition, Historian/Canary, Rockwell PLCs, etc.)
- Provide configuration, development, and break/fix day-to-day support of automation systems, ensures systems remain in compliance and follows safety guidelines.
- Manage automation system documentation (wiring diagrams, update loop drawings, software code, etc.) author SOPs, prepare technical and user documentation, and conduct system training.
- Support system maintenance and automation life cycle (review application patching, document test plans, and execute test scripts)
- Network with business users to educate and enhance data collection/contextualization (enable for future digital needs)
- Coordinate with business users for development of reports (batch, material, audit trails, etc.) to support efficient operations
- Support new client introduction and tech transfers of new products into the facility including new process equipment installation
- Support lab operations and lab equipment
Requirements
- Bachelor’s degree in Engineering, Science, or related technological field
- Minimum 2 years of relevant experience in industrial or process automation, controls, or system engineering.
- Working Knowledge of industrial networks, communication protocols, coding/configuring programmable logic controllers (Rockwell AB, Siemens).
- Control panel and automation hardware design experience
- Experience testing, commissioning and validating computer systems (CSV)
- Experience integrating industrial or manufacturing systems with enterprise IT platforms, including identity providers (e.g., Okta, Azure AD) for SSO, role-based access control, and centralized user management
- Effective leadership, interpersonal and communication skills (written and oral) are required
- Requires working in an industrial manufacturing environment including gowning
- Willingness to be in an on-call rotation in the future (once facility startup is complete) to support off hours troubleshooting and issue resolution
Desired
- Knowledge integrating/interfacing equipment to control systems via OPC, Ethernet IP, etc.
- Knowledge of SCADA systems (e.g. Ignition, OSISoft Pi), and Historians (e.g. Canary)
- Knowledge of the regulatory requirements for pharmaceutical applications such as 21CFR Part 11, Annex 11, and industry recommendations GAMP5
- Knowledge in Process Data Analytics.
- Working within a regulated industry in a GMP manufacturing environment
- Knowledge or experience working in a CDMO (contract manufacturing/development organization)
- Knowledge or experience working with Manufacturing Execution Systems such as Apprentice or Syncade
- Creative thinking, detail orientation, manual dexterity
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.