Senior Validation Engineer
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. NorthStar is 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 the Mo-99 is 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 Senior Validation Engineer is tasked with establishing Commissioning and Qualification (C&Q) policies/strategies, lead specific C&Q projects for radioactive pharmaceutical manufacturing equipment and processes and ensuring compliance with NorthStar’s quality standards/requirements and industry standards (FDA, EMA, ISO, ICH, etc.). The Senior Validation Engineer will drive C&Q project completion and compliance in a challenging and fast moving environment in a timely and efficient manner.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
Duties and Responsibilities
- Assists in the change management of facilities, utilities, systems, equipment (FUSE) and processes.
- Develop and manage the C&Q Programs/Processes including generating and maintaining site and project C&Q plans, overseeing C&Q schedules/activities, and coordinating various C&Q activities with cross functional teams.
- Develop and maintain NorthStar’s C&Q Training Module.
- Work with cross-functional teams in design reviews, impact assessments, generation of requirements, risk assessments and other identified C&Q deliverables.
- Manages, leads, and generates protocols/reports and executes of commissioning and qualification activities.
Bachelor’s degree in Engineering or a Science related field with six or more years of progressive experience in the pharmaceutical industry with at least four of those years acting in a Qualification/Validation role; or equivalent combination of education and experience. Experience working with current validation principles, standard concepts, practices and procedures, and requirements in a cGMP regulated environment is required. Demonstrated proficiency in five or more validation areas required. Experience with Statistical Analysis preferred.
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.
Senior Validation Engineer – 1800 Gateway Blvd. Beloit, WI 53511