Automation Engineer II / Senior Automation Engineer - Northstar Medical Radioisotopes Llc : Job Details

Overview 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. Position 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 Senior Automation Engineer have additional responsibilities, including responsibility for the design, planning, and execution throughout the product life cycle of systems automation technologies. This position will develop and execute automation engineering tasks from the concept phase. 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. Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination. The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures. The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions. Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols. This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment. In 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. Responsibilities

• 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.

The Senior Automation Engineer will have additional responsibilities, including:

• 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.
• Develop, plan, implement and support automation based projects 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, Revise and commission PLC, HMI and DCS based technologies.
• Provide engineering innovations that will improve process control and product quality.
• Provide advanced automation technical knowledge for troubleshooting, investigations and training.
• 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.

Qualifications Previous experience in working in cGMP environment is strongly preferred. Previous experience in a position working in an environment with open sources of radioactivity and an understanding of radioisotopes used in nuclear medicine desired. Specific knowledge of Siemens automation products and experience in a regulated pharmaceutical/medical device manufacturing environment is preferred. Automation Engineer II 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. Senior Automation Engineer Bachelor's degree in Engineering and minimum four (4) years of automation engineering design and implementation of control systems software experience within a regulated pharmaceutical/medical device manufacturing environment; or equivalent combination of education and experience. Experience with PLC, HMI and DCS in Product Development Life Cycle ranging from product specification and concept development to product release. 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. Location 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.