Aseptic Filling Process Engineer

Job Summary

Providing technical leadership and hands-on engineering support, the long-term remote Process Engineer - Aseptic Filling & Formulation Support will focus on aseptic fill/finish production, facility expansion initiatives, and manufacturing readiness activities within a GMP-regulated environment.

Key responsibilities

• Provide engineering support for sterile filling, formulation, and compounding operations while ensuring compliance with GMP requirements
• Support commissioning, qualification, startup, and operational readiness efforts for aseptic manufacturing equipment and production lines
• Collaborate with cross-functional teams to address deviations, CAPAs, change controls, and implement process improvements

Required qualifications

• 5+ years of process engineering experience in pharmaceutical, biotech, or sterile manufacturing environments
• Direct experience supporting aseptic filling operations or sterile injectable production processes
• Knowledge of formulation, compounding, filling systems, and aseptic processing technologies
• 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