MSAT Engineer

MS&T Engineer

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.

• 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.

• 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

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

North Star Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing…