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 Beloit, WI or 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.
Position
The Senior Chemical Process Engineer will assist the product and process development teams with creation and implementation of simple to complex manufacturing process designs in compliance with cGMP regulations. This position will be responsible for defining and creating new procedures for documenting or qualifying equipment/processing which can be transitioned to manufacturing production engineering team members.
Duties and Responsibilities
- Specify new equipment, implement solutions to complex requirements and create fixtures to support manufacturing processes in accordance to 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 introduction of new processes and manufacturing capability.
- Investigate, recommend and assist with design implementation and manufacturing process decisions to maximize internal expertise and productivity.
- Interpret detailed engineering drawings.
- Supervise up to one Laboratory Technician
- Act as pharmaceutical regulations subject matter expert for other engineers.
Qualifications
Bachelor’s degree in Chemical Engineering and 6 or more years of experience in a pharmaceutical manufacturing or development environment. Detailed knowledge of cGMP and other 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.
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.