Automation Engineer II

OverviewJoin 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.PositionThe 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 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 standby 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%).ResponsibilitiesDesign, 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 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.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.Continuously adapt to an ever-changing regulatory environment such that the Company is in compliance with current regulations.Develop and strengthen team capabilities through mentoring, training, and technical oversight of less experienced engineers.Early DevelopmentAfter 3 months, you will:Understand foundational cGMP radiopharmaceutical manufacturing principles.Complete radiation training in ALARA principles and isotope-specific safety protocols.Collaborate effectively with cross-functional teams, to ensure timely delivery of radiopharmaceuticals for cancer treatment.Gain hands-on experience with automation technology under the guidance of industry experts.After 6 months, you will:Develop advanced technical skills in handling automated processes and technologies, positioning yourself as a key player in an innovative and impactful field.Troubleshoot various automation systems.Implement automation changes to existing control system hardware and software, supervise hardware and software modifications done by outside vendors, and develop specification and test documentation.QualificationsBachelor’s degree in Engineering and minimum three (3) 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.Shift InformationThis 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%).BenefitsMedical, dental, and vision insuranceHealthcare Flex Spending Account (FSA) and Dependent Care FSACompany-paid short-term and long-term disabilityCompany-paid life insurance & AD&D coveragePet insurance401(k) matchPaid holidays and paid time off (PTO)Paid parental leaveBonus planEquity Incentive ProgramWorking ConditionsThis role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoorsNoise levels range from quiet to loud, depending on the work areaSpecific vision abilities, including near vision, visual acuity, and color discriminationPersonal Protective Equipment (PPE) is required and may include:Respirators, gloves, safety glasses, and full protective clothingCompliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensionsAs a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:Follow strict radiation safety proceduresParticipate in dosimetry monitoring and bioassay testing as part of the company protocolInform leadership of any health conditions that may affect product integrity, by cleanroom standardsIn addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders. The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.LocationNorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you’re drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families 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.Job SummaryID: Category: Engineering & TechnologyPosition Type: Regular Full-Time