Manager, Pharmaceutical Validation
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.
NorthStar develops, 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.
Position
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).
Duties and Responsibilities
- 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.
- Ensure that personnel are performing assigned tasks to standard and receive professional mentoring and development to stay current on internal policies and external requirements and trends as they apply to their specific role.
Qualifications
Bachelor’s Degree in Engineering or Science and five or more years of progressive relevant experience; or equivalent combination of education and experience. Two or more years of managerial experience required.
Experience developing and executing equipment impact assessments and validation test protocols for production facilities and equipment in a Pharmaceutical cGMP regulated environment required.
Location
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.
Manager, Pharmaceutical Validation – 1800 Gateway Blvd. Beloit, WI 53511