Senior MSAT Engineer

Overview

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.

Position

The Senior MSAT Engineer provides technical support and optimization of production processes, including the technology transfer from external clients or internal stakeholders (such as Process Development to Operations).

This role collaborates with cross-functional teams, including Operations, Process Development, Quality Assurance, Maintenance, Supply Chain and Safety to drive continuous improvement, maintain safe, compliant, and efficient production. The position will also be responsible for both internal and external technical transfer activities to support manufacturing readiness. This includes writing and updating of work instructions, batch records and other technical documents pertaining to the development and maintaining of GMP operations and assessment of process data. As well as provide technical input for deviations investigations, change controls, and CAPAs.

This role will provide on-the-floor and standby (on-call) technical support to manufacturing as required. All duties and responsibilities will be done in compliance with regulatory agency standards (including cGMP/FDA regulations, OSHA, DOT, and WI DHS).

Responsibilities

• 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.

Early Development

After 3 months, you will:

Understand foundational cGMP radiopharmaceutical manufacturing principlesComplete radiation training in ALARA principles and isotope-specific safety protocols.Collaborate effectively with cross-functional teams, to ensure timely delivery of radiopharmaceuticals for cancer treatment.Gain hands-on experience with production equipment and processes under the guidance of SME’s.

After 6 months, you will:

Display knowledge of existing NMR manufacturing processes, equipment and serve as a go-to resource for production issues.Produce documentation (procedures, protocols, reports, batch records, FMEA) that meets internal and regulatory expectations.Support troubleshooting tasks with SME’s and conducting thorough root cause analysisContribute with input into discussions around process robustness, optimization and capacity.

Qualifications

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.

Benefits

• Medical, dental, and vision insurance
• Healthcare Flex Spending Account (FSA) and Dependent Care FSA
• Company-paid short-term and long-term disability
• Company-paid life insurance & AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you’re drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation.

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.