Are you looking to be part of a game-changing organization that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team in Beloit, WI.
We develop, manufactures, and distributes radioisotopes used daily for patients needing medically important diagnostic imaging tests. Using novel and advanced technologies, NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader.
Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.
The Senior Manufacturing Engineer is responsible for executing manufacturing process development and production support of manufacturing equipment. This position will coordinate the ongoing product and process improvements to meet quality and production goals. The Senior Manufacturing Engineer will also be responsible for executing production support of isotope manufacturing.
All duties and responsibilities will be done in compliance with cGMP, FDA, and DHS regulations.
Duties and Responsibilities
- Execute manufacturing process development including radiochemical, mechanical, and electrical processes used in isotope manufacturing.
- Work directly with product development to develop/execute design transfer plans for new products.
- Execute manufacturing process development and documentation including work instructions and batch production records.
- Develop manual process to scale up/automation of manufacturing processes.
- Support production of chemical/fluid, filling, and packaging processes in hot cell/pharmaceutical clean room environments.
- Bachelor’s Degree in Engineering from an accredited college or university and six or more years of experience as a Manufacturing Engineer; or equivalent combination of education and experience.
- Experience executing process validation and documentation activities (IQ/OQ/PQ) is required.
- Strong experience with FDA regulations, cGMP regulations, and radiopharmacy/pharmaceutical/medical device industry is preferred.
We are headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.
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. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.
We are 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.