Radiopharmaceutical Manufacturing Process Engineer

NorthStar Medical Technologies; Beloit (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

NorthStar Medical Radioisotopes in Beloit, WI is seeking an engineer to join our fast-growing radiopharmaceutical manufacturing team. You will work cross-functionally to transfer and maintain processes, and assist in design transfers for new products, while helping optimize capacity and efficiency to meet quality goals.

Responsibilities include drafting procedures and reports, supporting risk assessments and CAPAs, and developing maintenance strategies for critical systems in a radiological

Qualifications

• Bachelor’s Degree in Mechanical, Industrial, Chemical, Nuclear, or related engineering field.

Responsibilities

• Work cross-functionally with other departments to 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.

Education

Bachelor’s Degree in Mechanical, Industrial, Chemical, Nuclear, or related engineering field

Job description

NorthStar Medical Radioisotopes in Beloit, WI is seeking an engineer to join our fast-growing radiopharmaceutical manufacturing team. You will work cross-functionally to transfer and maintain processes, and assist in design transfers for new products, while helping optimize capacity and efficiency to meet quality goals.

Responsibilities include drafting procedures and reports, supporting risk assessments and CAPAs, and developing maintenance strategies for critical systems in a radiological