Senior Manufacturing Science Engineer

5 days ago


Beloit, Wisconsin, United States NorthStar Medical Radioisotopes LLC Full time
Job Title: Senior Manufacturing Science Engineer

NorthStar Medical Radioisotopes LLC is seeking a highly skilled Senior Manufacturing Science Engineer to join our team. As a key member of our manufacturing team, you will be responsible for leading the development and execution of operations and maintenance procedures, ensuring effective process transfer between process development and operations.

Key Responsibilities:
  • Lead the development and execution of design transfer plans for new products and maintain process documentation for new and existing programs.
  • Generate manufacturing batch records, recipes, workflows, and standard operating procedures, ensuring that operational data, configurations, processes, and reports meet all regulatory requirements.
  • Identify and lead efforts to improve or optimize manufacturing capacity/efficiency by analyzing and planning material and workflow, layouts/space requirements, and equipment to meet quality and production goals.
  • Lead the creation and documentation of recommended maintenance strategies for relevant systems in collaboration with key stakeholders, applying risk-based decision-making practices and balancing performance, cost, and risk.
  • Provide production support for hot cells, automation equipment, and chemical/formulation, filling, and packaging processes in pharmaceutical clean room environments.
Requirements:
  • Bachelor's Degree in an applicable Engineering field such as Mechanical, Industrial, Chemical, or Nuclear or equivalent combination of education and experience.
  • Minimum four (4) years of experience in a life science, nuclear power, food processing, or medical device industry.
  • Strong experience with FDA regulations, cGMP regulations, and pharmaceutical industry.
Location:

NorthStar Medical Radioisotopes LLC is headquartered in Beloit, Wisconsin. This location is our primary manufacturing site and accommodates all of our corporate functions.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty.

We are an equal opportunity employer and welcome applications from diverse candidates.



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