Senior Cartridge Filling Process Engineer (Sterile Pharma)

Katalyst CRO; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced Process Engineer Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion in Raleigh, NC. This consultant will provide technical expertise for cartridge filling operations, equipment implementation, startup, commissioning, qualification, and process optimization.

You will work cross-functionally with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to ensure cartridge filling processes meet

Qualifications

• Bachelor's degree in a related engineering discipline.
• 5+ years pharma manufacturing experience, preferably sterile injectable operations.
• Hands-on cartridge filling experience.
• Strong understanding of FDA cGMP regulations, EU GMP, Annex 1, and aseptic manufacturing principles.
• Excellent troubleshooting, communication, and technical writing skills.

Responsibilities

• Provide technical expertise for cartridge filling operations, equipment implementation, startup, commissioning, qualification, and process optimization.
• Collaborate with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering to meet production, quality, and regulatory objectives.
• Support startup of new manufacturing operations with direct cartridge filling line experience.

Skills

Cartridge filling

Sterile manufacturing

cGMP compliance

Technical writing

Troubleshooting

Cross-functional

Education

Bachelor's degree in Mechanical Engineering

Tools

IQ/OQ

PQ

Job description

Katalyst CRO is seeking an experienced Process Engineer Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion in Raleigh, NC. This consultant will provide technical expertise for cartridge filling operations, equipment implementation, startup, commissioning, qualification, and process optimization.

You will work cross-functionally with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to ensure cartridge filling processes meet