Automation Engineer II - NorthStar Medical Radioisotopes

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to treat cancer, and customized radiopharmaceutical development services.

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

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 wth 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.

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.

• Design, revise and commission automation based systems with input from cross-functional teams and senior staff.
• Design, code, test, debug programs and systems.
• Implement automation changes to existing control system hardware and software; supervise hardware and software modifications done by outside vendors.
• 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 equipment.
• Support the validation of automation systems per cGMP and Regulatory guidance.
• 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.
• Continuously adapt to an ever-changing regulatory environment such that the Company is in compliance with current regulations.
• Work cross-functionally to support the design and installation of automation systems.

Bachelor’s degree in Engineering and minimum two (2) years of experience with a concentration in Automation or Process Control; or combination of education and experience. Knowledge of automation hardware design and maintenance required. Specific knowledge of Siemens automation products and experience in a regulated pharmaceutical/medical device manufacturing environment is preferred.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.  Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.  Under federal law, only truthful information may be provided on the Form I-9.

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.