Chemical Process Engineer II / Senior Chemical Process Engineer

Overview

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer, and customized radiopharmaceutical development services.

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 Chemical Process Engineer II 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.  The successful candidate will be familiar with manufacturing within a regulated industry such as medical device/pharmaceutical and possess in-depth engineering knowledge in science.

The Senior Chemical Process Engineer has additional responsibilities, further outlined below. 

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures.  The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions.  Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols.  This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment.  In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders. 

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

Responsibilities

• Specify new equipment, implement solutions for simple to complex requirements, and create fixtures to support manufacturing processes involving multiple unit operations 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.
• Anticipate and mitigate risk points. Make tradeoffs between design complexity, time and effort, schedule, cost and quality while meeting safety and regulatory demands.  Utilize escalation pathways as needed.
• Review and generate engineering and production documentation (procurement specs, mass balances, WIs/SOPs, URSs, reports, commissioning/qualification documents, etc.). Review and generate simple to complex engineering drawings (P&IDs, flow diagrams, assembly drawings, etc.).
• Assess and recommend continuous improvement opportunities.
• Demonstrate proficiency in understanding and applying pharmaceutical regulations to process development, design and implementation.
• Identify, develop, and implement new tools and technologies to improve processes and/or company policies/procedures.
• Participate in and support project teams. May serve as Engineering technical lead in cross-functional groups to identify, and complete action items to meet project timelines.
• Continuously adapt to an ever-changing regulatory environment such that the Company is in compliance with current regulations. Make adjustments to work plans accordingly.

The Senior Chemical Process Engineer will have additional responsibilities, including:

• Work with project management and other technical leads to develop and maintain project schedule.
• Oversee tasks performed by Engineering Intern.
• Demonstrate expertise in understanding and applying pharmaceutical regulations to process development, design and implementation. Provide guidance to other engineers or team members.

Qualifications

Experience with radioactive processing preferred.

Chemical Process Engineer II

Bachelor’s degree in Chemical Engineering or other Engineering discipline and a minimum of two (2) years of experience in a regulated environment such as medical device or pharmaceutical manufacturing or a development environment; or equivalent combination of education and experience.  Knowledge and skill in operation of scientific equipment is required. 

Knowledge of product development life cycle ranging from product specification and concept development to product release (including equipment/process startup, commissioning, verification, qualification) in an environment subject to cGMP or other pharmaceutical regulations (e.g., FDA, EU, and ICH) is desired.

Senior Chemical Process Engineer

Bachelor’s degree in Chemical Engineering or other Engineering discipline and a minimum of four (4) years of experience in a regulated environment such as medical device or pharmaceutical manufacturing or a development environment; or equivalent combination of education and experience. 

Knowledge and skill in operation of scientific equipment and product development life cycle ranging from production specification and concept to product release (including equipment/process startup, commissioning, verification, qualification) in an environment subject to cGMP or other pharmaceutical regulations (e.g., FDA, EU, and ICH) is required. 

Demonstrated success in managing multiple tasks of high priority and complexity is desired.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.  Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.  Under federal law, only truthful information may be provided on the Form I-9.

Location

***Please note that this position may be based from either Beloit (preferred) or Madison, Wisconsin.  Travel between locations should be expected.***

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.

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. Madison was named first on Livability's top 100 places to live in 2022 and U.S. News ranked Wisconsin's capital city third for the best quality of life in the U.S. in 2024.

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.