Process Engineer, Aseptic

What you'll do

• Solve complex problems related to aseptic capital projects and process troubleshooting.
• Serve as the organization spokesperson for advanced projects including equipment selection.
• Advise management and operating sites on the application of new advanced processing equipment.
• Ensure quality and effectiveness of aseptic solutions through sound design and risk assessments.
• Evaluate and integrate engineering advances to solve operational problems.
• Provide technical direction and feedback to cross-functional teams.
• Manage project timelines and ensure timely completion of assigned tasks.

What we're looking for

• MS or PhD in Mechanical Engineering, Chemical Engineering, or a related field.
• 6 to 8 years of engineering experience in pharmaceutical aseptic process design, equipment selection, and operation.
• Demonstrated expertise as a subject matter expert in the aseptic discipline.
• Experience leading FMEA, risk assessments, and investigations for aseptic pharmaceutical processes.
• Knowledge of aseptic fill finish technology, microbial control, environmental monitoring, and single-use systems.
• Knowledge of regulatory requirements in Europe and the US, including ISPE, AMSE, ISO, and USP standards.
• Understanding of equipment control, SCADA, MES levels, and robotics applications.
• Negotiation skills and the ability to reconcile differences.