Lead Manufacturing Engineer
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 proactive, collaborative, can-do mindset to join our rapidly growing team.
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 Lead Manufacturing and Service Engineer is responsible for leading and mentoring other Engineers and/or Technicians/Specialists. The position requires a hands-on leader that can engage directly in problem-solving and is responsible for executing manufacturing process development and production support of manufacturing process and equipment at the Columbia, MO facility. This position will coordinate the ongoing product and process improvements to meet quality and production goals.
Duties and Responsibilities
- Manage a team of Engineers and/or Engineering Technicians/Specialists to support the Columbia facility production process and process-related equipment.
- Execute manufacturing process development and documentation including work instructions and batch production records.
- Specify new equipment, implement solutions to complex requirements and create fixtures to support manufacturing processes in accordance to cGMP regulations
- Manage Process Equipment/instrument calibration and maintenance for the Columbia site. Ensure proper and compliant equipment lifecycle tracking, including physical and digital equipment file creation/maintenance.
Bachelor’s Degree in Engineering from and 7+ 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 the pharmaceutical/medical device industry is 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.