Process Engineer

Responsibilities

• Provide technical expertise for cartridge filling operations
• Support equipment implementation, startup, commissioning, qualification, process optimization, and commercial manufacturing
• Work closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering
• Ensure cartridge filling processes consistently meet production, quality, and regulatory objectives
• Support the successful startup of new manufacturing operations

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

Most Important Skills Needed

• Direct cartridge filling line experience
• Process Engineering within sterile pharmaceutical manufacturing
• Aseptic filling operations
• Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)
• Process optimization and manufacturing troubleshooting
• GMP manufacturing experience
• Root cause investigations, CAPA, and deviation support
• Cross-functional collaboration with Manufacturing, Validation, Automation, and Quality
• Technical documentation, engineering studies, and protocol development