Chemical Process Engineer II / Senior Chemical Process Engineer

Northstar Medical Radioisotopes - Madison, WI

Full-time - Mid Level

Madison, WI

Chemical Manufacturing

About the position

The Chemical Process Engineer II at NorthStar Medical Radioisotopes plays a crucial role in assisting product and process development teams to create and implement manufacturing process designs that comply with cGMP regulations. This position involves defining and creating new procedures for documenting or qualifying equipment and processes, ensuring a smooth transition to manufacturing production engineering. The ideal candidate will have experience in a regulated industry, particularly in medical device or pharmaceutical manufacturing, and possess strong engineering knowledge.

Responsibilities

• Specify new equipment, implement solutions for simple 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 in manufacturing processes.
• Make tradeoffs between design complexity, time and effort, schedule, cost, and quality while meeting safety and regulatory demands.
• Review and generate engineering and production documentation including procurement specs, mass balances, WIs/SOPs, URSs, and commissioning/qualification documents.
• Review and generate engineering drawings such as P&IDs, flow diagrams, and assembly drawings.
• Assess and recommend continuous improvement opportunities in processes.
• 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 company policies/procedures.
• Participate in and support project teams, potentially serving as Engineering technical lead in cross-functional groups.

Requirements

• Bachelor's degree in Chemical Engineering or other Engineering discipline.
• Minimum of two years of experience in a regulated environment such as medical device or pharmaceutical manufacturing, or equivalent combination of education and experience.
• Knowledge and skill in operation of scientific equipment is required.
• Knowledge of product development life cycle from product specification and concept development to product release in a cGMP environment is desired.
• Experience with radioactive processing preferred for the Senior Chemical Process Engineer role.

Nice-to-haves

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

Benefits

• Health and life insurance
• 401K match
• Paid holidays
• Paid time off
• Annual bonus eligibility
• Equity incentive plans