Lead Sterile Cartridge Filling Process Engineer

Katalyst CRO; Frederick (MD); On-site; USD 95,000 - 135,000; Full time

Job summary

Katalyst CRO is seeking an experienced Process Engineer for cartridge filling in a large-scale sterile pharmaceutical expansion. The consultant will lead technical efforts in equipment implementation, startup, commissioning, qualification, and process optimization to ensure compliant, efficient production.

Collaborating with QA, Validation, Automation, Maintenance, and Project Engineering, you will drive startup success for new manufacturing operations and maintain exceptional process control in

Qualifications

• Bachelor's degree in Mechanical, Chemical, Biomedical, Manufacturing, or related engineering discipline.
• 5+ years of pharmaceutical manufacturing experience, preferably sterile injectable operations.
• Hands-on cartridge filling experience is required.
• Strong knowledge of FDA cGMP, EU GMP, Annex 1, and aseptic manufacturing.

Responsibilities

• Provide technical expertise for cartridge filling operations during expansion.
• Support equipment implementation, startup, commissioning, qualification, and process optimization.
• Work with QA, Validation, Automation, and Manufacturing to meet regulatory objectives and startup goals.

Skills

Cartridge filling

Sterile manufacturing

Aseptic processing

Equipment startup & qualification

Process optimization

GMP compliance

Root cause investigations

Cross-functional collaboration

Technical documentation

Education

Bachelor's degree in Mechanical Engineering or related field

Job description

Katalyst CRO is seeking an experienced Process Engineer for cartridge filling in a large-scale sterile pharmaceutical expansion. The consultant will lead technical efforts in equipment implementation, startup, commissioning, qualification, and process optimization to ensure compliant, efficient production.

Collaborating with QA, Validation, Automation, Maintenance, and Project Engineering, you will drive startup success for new manufacturing operations and maintain exceptional process control in