Senior Cartridge Filling Process Engineer Sterile Pharma

Creative Solutions Services, LLC; Frederick (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Process Engineer – Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. The role focuses on cartridge filling operations, equipment implementation, startup, commissioning, qualification, and optimization to enable commercial manufacturing.

The candidate will work cross-functionally with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to ensure production and regulatory

Qualifications

• Bachelor's degree in Mechanical, Chemical, Biomedical, Manufacturing, Industrial or 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.

Responsibilities

• Provide technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and commercial manufacturing.
• Collaborate with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering to meet production and regulatory objectives and support startup of new manufacturing operations.
• Direct experience with cartridge filling lines required; candidates with syringe filling experience only will not be considered.

Skills

Cartridge filling experience

Process engineering

Aseptic filling operations

Equipment startup and qualification

GMP manufacturing experience

Root cause investigations

Cross-functional collaboration

Technical documentation

Education

Bachelor's degree in engineering

Job description

Creative Solutions Services, LLC is seeking an experienced Process Engineer – Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion. The role focuses on cartridge filling operations, equipment implementation, startup, commissioning, qualification, and optimization to enable commercial manufacturing.

The candidate will work cross-functionally with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to ensure production and regulatory