Bachelor's degree in Mechanical, Chemical, Biomedical, Manufacturing, Industrial Engineering, or related field
5+ years of experience in pharmaceutical manufacturing, focusing on sterile injectables
Hands-on experience specifically with cartridge filling operations
Strong knowledge of FDA cGMP regulations and EU GMP, particularly Annex 1
Experience with equipment validation and manufacturing startup activities
Proficient troubleshooting, communication, and technical writing skills
Responsibilities
Support large-scale sterile pharmaceutical manufacturing expansion as a Process Engineer for cartridge filling operations
Provide technical expertise for equipment implementation, startup, commissioning, and qualification
Ensure cartridge filling processes meet production, quality, and regulatory objectives
Collaborate with Manufacturing, Quality Assurance, Validation, and other departments for successful operations
Focus on troubleshooting and optimization of cartridge filling processes
Benefits
Opportunities for career advancement within a growing organization
Access to cutting-edge technology and practices in pharmaceutical manufacturing
Collaborative work environment with cross-departmental teams
Professional development through continuous learning and training programs
Full Job Description
Responsibilities:
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.
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 (Required)
Process Engineering within sterile pharmaceutical manufacturing
septic 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
