Manufacturing Science & Technology Engineer
About the role
Join a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At NorthStar Medical Radioisotopes, you’ll work at the forefront of technological innovation, contributing to scientific excellence through first-in-kind electron accelerator technology and integrated campus capabilities in radiopharmaceutical manufacturing. This role offers exceptional career growth and professional development opportunities in a specialized, fast-growing field with a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need.
Responsibilities
- Work cross-functionally with other departments to effectively transfer and maintain processes in the facility.
- Assist in developing and executing design transfer plans for new products and maintain process documentation for new and existing programs.
- Assist in improving and optimizing manufacturing capacity and 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/preventive action identification.
- Execute production support of hot cells, automation equipment, chemical/fluid, filling, and packaging processes in pharmaceutical clean room environments as required.
Requirements
- Bachelor’s Degree in an applicable Engineering field such as Mechanical, Industrial, Chemical, or Nuclear, or equivalent combination of education and experience.
- 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.
Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.
Benefits
Competitive benefits package supported by world-class facilities.