Manufacturing Science & Technology Engineer

NorthStar Medical Technologies; Beloit (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

NorthStar Medical Radioisotopes in Beloit, WI is seeking an engineer to join our fast-growing radiopharmaceutical manufacturing team. You will work cross-functionally to transfer and maintain processes, and assist in design transfers for new products, while helping optimize capacity and efficiency to meet quality goals.

Responsibilities include drafting procedures and reports, supporting risk assessments and CAPAs, and developing maintenance strategies for critical systems in a radiological

Qualifications

• Bachelor’s Degree in Mechanical, Industrial, Chemical, Nuclear, or related engineering field.

Responsibilities

• Work cross-functionally with other departments to transfer and maintain processes in the facility.
• Assist in developing/executing design transfer plans for new products and maintain process documentation for new and existing programs.
• Assist in improving/optimizing manufacturing capacity/efficiency by analyzing and planning material and workflow, layouts/space requirements, and equipment to meet quality and production goals.
• Assist in preparing and executing procedures, protocols, reports, and plans for assigned processes including factory and site acceptance testing and qualification activities in a radiological environment.
• Create and document recommended maintenance strategies for relevant systems in collaboration with key stakeholders, applying risk‑based decision-making practices and balancing performance, cost and risk.
• Review and investigate system/equipment failure incidents, formulate, and record lessons learned, and continually improve and optimize system operation and maintenance strategies through implementation of corrective and preventive actions.
• Support the creation of risk assessments, gap analyses, deviations, change controls, and CAPAs including determination of product or process impact, root‑cause analysis, and corrective action and preventative action identification.
• Executes production support of hot cells, automation equipment, chemical/fluid, filling, packaging processes in pharmaceutical clean room environments as required.

Education

Bachelor’s Degree in Mechanical, Industrial, Chemical, Nuclear, or related engineering field

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.

• Work cross-functionally with other departments to effectively transfer and maintain processes in the facility.
• Assist in developing/executing design transfer plans for new products and maintain process documentation for new and existing programs.
• Assist in improving/optimizing manufacturing capacity/efficiency by analyzing and planning material and workflow, layouts/space requirements, and equipment to meet quality and production goals.
• Assist in preparing and executing procedures, protocols, reports, and plans for assigned processes including factory and site acceptance testing and qualification activities in a radiological environment.
• Create and document recommended maintenance strategies for relevant systems in collaboration with key stakeholders, applying risk‑based decision‑making practices and balancing performance, cost and risk.
• Review and investigate system/equipment failure incidents, formulate, and record lessons learned, and continually improve and optimize system operation and maintenance strategies through implementation of corrective and preventive actions.
• Support the creation of risk assessments, gap analyses, deviations, change controls, and CAPAs including determination of product or process impact, root‑cause analysis, and corrective action and preventative action identification.
• Executes production support of hot cells, automation equipment, chemical/fluid, filling, packaging processes in pharmaceutical clean room environments as required.

Bachelor’s Degree in applicable Engineering field such as Mechanical, Industrial, Chemical or Nuclear or equivalent combination of education and experience.

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.