Automation Engineer II

NorthStar Medical Technologies; Beloit (WI); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

NorthStar Medical Radioisotopes in Beloit, WI, is seeking an Automation Engineer to design, code, test, and document PLC, HMI, and DCS systems for GMP production. You will support new designs and maintain existing production controls in a fast-growing radiopharmaceutical environment.

A Bachelor’s degree in Engineering and 3+ years in automation or process control are required; Siemens TIA experience and familiarity with regulatory standards such as 21 CFR Part 11 preferred.

Qualifications

• Bachelor’s degree in Engineering and minimum three years in Automation/Process Control, or equivalent mix of education and experience.
• Knowledge of automation hardware design and maintenance; Siemens experience preferred in a regulated pharma/medical device setting.

Responsibilities

• Design, 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 for new designs and current production systems.
• Implement automation changes to existing control system hardware and software, supervise vendor work, and develop specs and test docs.
• Create, modify and maintain automation system documentation in a cGMP state.
• Troubleshoot automation systems and train operations personnel on automated operations.
• Ensure maintenance and availability of automation system controls and equipment.
• Provide automation knowledge for troubleshooting, investigations and training related to software and hardware.
• Support validation of automation systems per cGMP and regulatory guidance.
• Develop data interfaces for data acquisition, integrity and retention, including 21 CFR Part 11 compliance.
• Understand electrical schematics, P&ID drawings and system integration (Siemens TIA) and NFPA/UL/CE/NEC requirements.
• Contribute to process risk reviews and modify equipment/designs to ensure safe operation.

Skills

PLC

HMI

DCS

Siemens TIA

Electrical schematics

P&ID drawings

21 CFR Part 11

Regulatory knowledge

Mentoring

Training

Education

Bachelor's degree in Engineering

Tools

Siemens TIA Portal

Siemens automation products

Job description

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.

• Design, 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.

Bachelor’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.