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, ensuring compliance with GMP requirements while overseeing aseptic fill/finish production and facility expansion initiatives.

Key responsibilities

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

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
• 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