The Process Engineer - Cartridge Filling provides technical expertise and engineering support for sterile pharmaceutical manufacturing operations, focusing on cartridge filling processes, equipment implementation, startup, qualification, and process optimization. This role supports large-scale manufacturing expansions by collaborating with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering teams to ensure reliable, compliant, and efficient production. The engineer will drive process improvements, troubleshoot manufacturing issues, support validation activities, and ensure compliance with FDA cGMP, EU GMP Annex 1, and aseptic manufacturing requirements.
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
- 5+ years of pharmaceutical manufacturing experience, preferably supporting sterile injectable operations.
- Hands-on cartridge filling experience is required.
- Strong understanding of FDA cGMP regulations, EU GMP, Annex 1, and aseptic manufacturing principles.
- Experience supporting equipment validation, process qualification, and manufacturing startup activities.
- Excellent troubleshooting, communication, and technical writing skills.
- Seeking an experienced Process Engineer - Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. This consultant will provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial manufacturing.
- Working closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will ensure cartridge filling processes consistently meet production, quality, and regulatory objectives while supporting the successful startup of new manufacturing operations.
- Direct experience supporting cartridge filling lines is required. Candidates with experience limited to syringe filling will not be considered.