Senior MSAT Engineer

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.Evaluate existing manufacturing processes and maintenance strategies and identify areas for improvement in efficiency, productivity, process capability, risk, and cost reduction.Lead or assist in developing/executing design transfer plans for new products and maintain batch production records and process documentation for new and existing programs.Lead or assist in preparing and executing cGMP and non-cGMP procedures, protocols, reports, and plans for chemical/fluid, filling, hot cells, and packaging processes in radiological and/or clean room environments.Play active role in developing and driving engineering strategies around processing capabilities, capacity and optimization that align with organizational priorities.Support the creation and documentation of maintenance strategies for relevant systems in collaboration with key stakeholders, applying risk-based decision-making practices and balancing performance, cost and risk.Lead production support for radiological hot cells, irradiation equipment, and chemical/formulation, filling, and packaging processes, including troubleshooting and maintaining, or updating/upgrading fixtures, equipment and systems.Support assigned maintenance delivery tasks as per system maintenance strategies and procedures.Support the investigation of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.Prepare and present risk assessments and status updates to upper management.Assist in developing training programs and provide training on process systems and equipment. MINIMUM EDUCATION/EXPERIENCE:Bachelor’s Degree in a relevant STEM field and minimum six (6) years of relevant progressive experience within a cGMP or other highly regulated environment; or equivalent combination of education and experience.  Knowledge of and experience with the operation of chemical processing or irradiation equipment and manufacturing.  PREFERRED EDUCATION/EXPERIENCE:Master’s Degree in a relevant STEM field and four (4) years of relevant progressive experience within a cGMP or other highly regulated environment; or equivalent combination of education and experience.  Experience in radiopharmaceutical production.Experience working with the operation of chemical processing equipment and manufacturing.Experience working with hot cells and cooling systems. 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.