Bachelor's degree in relevant engineering discipline
5+ years of experience in pharmaceutical manufacturing, especially sterile injectables
Hands-on experience with cartridge filling operations
In-depth knowledge of FDA cGMP regulations and aseptic manufacturing principles
Experience in equipment validation and process qualification activities
Strong troubleshooting and communication skills
Responsibilities
Support technical expertise for large-scale cartridge filling operations
Ensure production and quality objectives are met for sterile manufacturing
Facilitate equipment implementation and validation during startup
Collaborate across multiple departments including Quality Assurance and Engineering
Lead process optimization for cartridge filling lines
Conduct root cause analyses and support corrective actions
Benefits
Collaborative work environment across multiple engineering and manufacturing teams
Opportunity to influence a large-scale pharmaceutical expansion project
Hands-on role impacting product quality and compliance
Involvement in cutting-edge sterile manufacturing operations
Professional development through cross-functional collaboration
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
