Automation Engineer II

Overview

North Star Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.

At the forefront of North Star’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life‑saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world‑class facilities and a competitive benefits package.

The Automation Engineer II will contribute to the development and execution of automation engineering tasks through design, planning, procurement, and execution, as well as coordinating with vendors and contractors. Some of these tasks include programming of PLC and HMI as well as associated documentation. Also included are assisting in the development and implementation of Manufacturing Execution Systems (MES) and associated networking and data management systems.

This individual will be required to work with cross functional teams, including RA/QA and Process Engineering to apply efficient cGMP processes to preserve data integrity and the quality of the drug product, including the safety of all production and non‑production personnel.

The Automation Engineer II is responsible for performing automation engineering tasks for the support of automated production systems at the Beloit campus. This includes the support of existing production system automation control software and hardware and transfer of automated equipment/systems and the associated control systems into production and providing the ongoing support of these systems to include some on‑call support.

The Automation Engineer II will have responsibility on a project level from conception to final commissioning and validation.

This position supports production in a 24‑hour manufacturing facility and may require availability to provide support during evenings, nights, weekends, and some holidays, as needed (generally up to 15%).

• Design, revise and commission PLC, HMI, and DCS based automation systems with input from cross‑functional teams and senior staff.
• Design, code, test, debug and document programs and systems as needed in support of new designs and current production systems.
• Implement automation changes to existing control system hardware and software, supervising hardware and software modifications done by outside vendors, and development of specifications and testing documentation.
• Create, modify, and maintain automation system documentation including project documentation, specification documents, and SOPs in a cGMP compliant state.
• Troubleshoot various automation systems and provide training to operations personnel on automated operations.
• Ensure effective maintenance and availability of automation system controls and equipment.
• Provide automation technical knowledge for troubleshooting, investigations and training associated with Automation software as well as integrated automation system related hardware including sensors, valves, pneumatics, conveyors, robotics, vision systems, filling systems, automatic packaging equipment, etc.
• Support the validation of automation systems per cGMP and Regulatory guidance.
• Provide automation system design in relation to data acquisition, integrity and retention, required for system tracking and trending, including development of data interfaces between disparate systems to include 21
  
  CFR Part 11 and Annex 11.
• Understand and create electrical schematics and wiring diagrams and present drawings and project progress to peers and management.
• Participate in process risk and hazard reviews and modify equipment/designs as necessary to ensure safe operation and appropriate specifications are captured.
• Understand and interpret P&, electrical schematics and…