Process Engineer - Aseptic Filling

Job Summary

Providing technical leadership in a long-term remote contract role, the Process Engineer - Aseptic Filling will support sterile manufacturing operations, focusing on aseptic fill/finish production, facility expansion, and technology transfers within a GMP-regulated environment.

Key responsibilities

• Provide engineering support for sterile filling, formulation, and compounding operations in compliance with GMP requirements
• Support commissioning, qualification, and operational readiness efforts for aseptic manufacturing equipment and production lines
• Collaborate with cross-functional teams to address deviations, CAPAs, and process improvements while serving as a technical representative for capital projects

Required qualifications

• 5+ years of process engineering experience in pharmaceutical, biotech, or sterile manufacturing environments
• Direct experience with aseptic filling operations and sterile injectable production processes
• Knowledge of formulation, compounding, and aseptic processing technologies such as isolators or RABS
• Experience with validation activities, technology transfers, and capital project execution
• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related technical discipline