Senior Chemical Process 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 pro-active, collaborative, can-do mindset to join our rapidly growing team in Madison, 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.

The Senior Chemical Process Engineer will lead the product and process development and implementation of simple to complex manufacturing process designs in compliance with cGMP regulations. This position will also be responsible for defining and creating new procedures for documenting or qualifying equipment/processing which can be transitioned to manufacturing production engineering team members. 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
• Specify new equipment, implement solutions to complex requirements, and create fixtures to support manufacturing processes in accordance with cGMP regulations.
• 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.
• Provide transition training to manufacturing personnel for the introduction of new processes and manufacturing capability.
• Anticipate and mitigate risk points. Make tradeoffs between design complexity, time and effort, schedule, cost, and quality while meeting safety and regulatory demands.
• Interpret detailed engineering drawings.

Bachelor’s degree in Chemical Engineering and 6 or more years of experience in a medical device or pharmaceutical manufacturing or development environment; or equivalent combination of education and experience. Detailed knowledge of cGMP and other medical devices/pharmaceutical regulations such as FDA, EU, and ICH guidelines. Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is essential; utility, facility, and process validation experience is a plus. Demonstrated success in managing multiple projects of high complexity. Experience with ancillary biopharma processing and utilities that includes clean in place systems and USP water/WFI generation preferred.

Madison isn’t just the “Capital City,” it also houses NorthStar Medical Radioisotopes’ Research and Development facilities.
The Madison region is a place where dynamic, talented, innovative and hardworking people want to be. We know this because the region is growing at a faster rate than the state and the nation. Madison, Wis. was named first on Livability’s top 100 places to live in 2014.

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.

Chemical Process Engineer II – 3060 Progress Rd. Madison, WI