Manager, Pharmaceutical Validation
Are you looking to be part of something extraordinary and meaningful that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking motivated individuals like you to join our rapidly growing team in Beloit, WI. Innovative technology, Opportunities for career advancement, and competitive compensation are just the beginning at NorthStar. In addition to health and life insurance, paid holidays, and paid time off, all NorthStar employees are eligible on Day One for our annual bonus and equity incentive plans.
NorthStar develops, manufactures and distributes radioisotopes that are used daily for patients needing medically important diagnostic imaging tests. Our novel, high technology approaches have enabled NorthStar to be the first company in nearly 30 years to produce the radioisotope Mo-99 in the United States. NorthStar’s processes are non-uranium based and designed to help minimize waste while meeting the highest quality standards. The Mo-99 is used in NorthStar’s RadioGenix® System, an isotope separation platform used by radiopharmacies across the country to produce the imaging radioisotope Tc-99m. NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader. Beyond Mo-99, we have a pipeline of other novel and medically important isotopes which can further grow our business and provide development opportunities for our employees.
Working with this novel and advanced technology is challenging yet rewarding for talented individuals who want to make a difference and be part of an exciting and rapidly growing business. NorthStar’s people drive our solutions and our success, and we are committed to ensuring that we provide fulfilling work experiences and valuable development opportunities.
The Manager, Pharmaceutical Validation is within the Engineering Team and is responsible for the development and management of the NorthStar validation program and validation personnel. The scope of the work controlled by this position includes Pharmaceutical/Isotope/Medical Device Manufacturing Equipment/Facilities Assessment (for product quality impact), Commissioning (GMP and non-GMP), and Qualification (IQ/OQ).
- Develop and drive the overall validation strategy for NorthStar Manufacturing systems through cross-functional teams including quality, engineering, and manufacturing as well as outside consultants.
- Lead and personally develop procedures in line with the strategy
- Provide subject matter expertise to development teams on how to create validation protocols and strategies.
- Bachelor’s Degree in Engineering or Science and five or more years of progressive relevant experience
- Experience developing and executing equipment impact assessments and validation test protocols for production facilities and equipment in a Pharmaceutical cGMP regulated environment required.
Does this sound like you? If so, apply today!
NorthStar Medical Radioisotopes is 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.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.
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
Pharmaceutical Validation Beloit WI