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 Columbia, MO.
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.
The Manufacturing Engineer is responsible for the development and implementation of simple to complex manufacturing process designs for the NorthStar radioisotope manufacturing team in compliance with cGMP regulations. This position will be responsible for defining and creating new procedures for documenting or qualifying equipment and processes used in the manufacturing of radioisotopes. This position will also assist in overseeing the day-to-day production requirements of the Mo-99 fill process at the NorthStar Columbia facility.
The successful candidate will be familiar with manufacturing within the medical device/pharmaceutical industry and possess in-depth engineering knowledge in science.
Duties and Responsibilities
- Collaborate with internal and external stakeholders and suppliers to design, purchase, and build equipment and processes that meet the needs of NorthStar’s products, employees, and customers
- Anticipate and troubleshoot process and procedural issues related to the manufacturing and packaging of Mo-99 and other radioisotopes as needed. Make tradeoffs between design complexity, time and effort, schedule, cost, and quality while meeting safety and regulatory demands.
- Assist in the management of the operational teams involved in the radioisotope fill process at the NorthStar-Columbia operation.
- Generate, edit, and issue master batch documentation (MBR’s) specific for the radioisotope fill process and related equipment and cleaning activities. Review executed batch documentation as needed.
Bachelor’s Degree in Engineering from an accredited college or university and 1-3 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. Experience with FDA regulations, cGMP regulations, and pharmaceutical/medical device industry are desired. Experience with radioactive processing preferred.
NorthStar’s isotope production employees are based in Columbia, Mo. Our administrative offices are at the recently opened Missouri Innovation Center, and the team operates state-of-the-art processing equipment in the NorthStar Isotope Production suites at the Missouri University Research Reactor Campus, just a short walk away. From picturesque parks and clever cuisine to amazing art and superb shopping, visitors find that Columbia is more than a college town – it is a vibrant and sophisticated city.
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.
Manufacturing Engineer – 1601 South Providence Rd. Columbia, MO