Automation Engineer II / Senior Automation Engineer - NorthStar Medical Radioisotopes

Accelerate your career with NorthStar!

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.  We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities. 

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, paid parental leave 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 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/Senior 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 has 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.  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.

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 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; 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 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.

The Senior Automation Engineer will have additional responsibilities, including:

• 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.
• Support definition and implementation of best practice automation technical standards and procedures.
• Provide engineering innovations that will improve process control and product quality.

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories, clean rooms, and vaults.
• Trained on ALARA principles and RAD safety.
• Be able to perform know how to enter and exit a Rad area.

 After 6 months you will:

• Be functionally operational to support 24/7 automation control systems.
• Be functionally operational for supporting campus functions for automation systems designated.
• Provide support to site operational readiness to include administrative requirements.  
• Be functionally operational to coordinate with team members from many groups.

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 and ongoing support of control systems software and automation hardware experience within a regulated pharmaceutical/medical device/food 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 and ongoing support.

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.

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.

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.