Manufacturing Science & Technology Engineer

NorthStar Medical Radioisotopes•Beloit, WI

15h•Onsite

About The Position

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. The MS&T Engineer is responsible for supporting both internal and external manufacturing and technical transfer activities to support manufacturing readiness. This includes assisting in the development of operations and maintenance procedures and other necessary documentation to ensure effective process transfer between process development and operations. The MS&T Engineer is responsible for developing and evaluating manufacturing processes and implementing equipment and tools for production. This position will assist in the coordination of product and process improvements to meet quality and production goals. The MS&T Engineer is a key role in relation to system management and performance ensuring that operating, maintenance strategies are optimized through sound decision making and planning, and continuously improved through feedback of operating experience and data. The MS&T Engineer will gain an appropriate level of expertise in relation to allocated systems and equipment with an overall understanding of the drivers and limitations of system reliability and the ability to provide sound technical support, advice, and training to operations and maintenance functions. All duties and responsibilities will be done in compliance with applicable regulatory agency standards.

Requirements

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.

Responsibilities

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.