Senior Automation Engineer

NorthStar Medical Radioisotopes•Beloit, WI

13d•Onsite

About The Position

Join the best radiopharmaceutical company in the world! If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. NorthStar 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 NorthStar’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 Senior Automation Engineer is responsible for the design, planning and execution throughout the product life cycle of system automation technologies. The Senior Automation Engineer will develop and execute automation engineering tasks from concept phase through design, planning, procurement and execution, as well as coordinating with vendors and contractors. The Senior Automation Engineer is responsible 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 Senior Automation Engineer is responsible for working with cross functional teams to apply efficient cGMP processes, which preserve data integrity and the quality of the drug product, including the safety of all production and non-production personnel. The Senior Automation Engineer will have responsibility on a program level from conception to final commissioning and validation. The Senior Automation Engineer is critical to the company's continued success and growth by providing technical leadership with regards to system automation with increasing levels of productivity and safety.

Requirements

Bachelor’s degree in Engineering and minimum six (6) years of automation engineering design and implementation and ongoing support of control systems software and automation hardware experience; or equivalent combination of education and experience.
Experience with PLC’s and HMI’s in Product Development Life Cycle ranging from product specification and concept development to product release.

Nice To Haves

Siemens TIA preferred

Responsibilities

Design, Revise and commission PLC, HMI and DCS based technologies with input from cross-functional teams while providing support and direction for junior 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.
Develop, plan, implement and support automation based projects, improvement, upgrades, and solutions in collaboration with cross-functional teams, including determination and delivery on cost, time and quality to ensure the sustained production, with an overall focus on productivity and safety. The projects may be within new facilities and/or retrofit of existing.
Design and implement integration strategies for laboratory and other off the shelf equipment used the production processes.
Lead responsibility for defining the overall automation strategy and architecture for the assigned area of responsibility. This would include process control, process control network, batch/recipe processing, and integration with MES systems.
Create, modify, and maintain automation system and documentation, including automation 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 advanced 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 advanced 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 21CFR 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.
Thoroughly understand and interpret P&ID drawings, electrical schematics and wiring diagrams; PLC based logic and system integration (Siemens TIA preferred); and NFPA, UL, CE, NEC requirements.
Support definition and implementation of best practice automation technical standards and procedures.
Continuously adapt to an ever-changing regulatory environment such that the Company is in compliance with current regulations.
Provide engineering innovations that will improve process control and product quality.