Bachelor's degree in a relevant engineering discipline (Mechanical, Chemical, Biomedical, etc.)
5+ years of experience in pharmaceutical manufacturing, especially in sterile injectable operations
Direct hands-on experience with cartridge filling lines
Strong knowledge of FDA cGMP regulations and EU GMP standards
Experience in equipment validation and process qualifications
Responsibilities
Provide technical expertise for cartridge filling operations and support equipment implementation
Ensure cartridge filling processes meet production, quality, and regulatory standards during new operations startup
Directly support commissioning, qualification, and optimization of filling processes
Collaborate with cross-functional teams including Manufacturing, QA, and Validation
Troubleshoot manufacturing issues and support root cause investigations
Benefits
Collaborative work environment with cross-functional teams
Opportunity to contribute to a large-scale manufacturing expansion
Engagement in compliance with regulatory manufacturing standards
Hands-on involvement in innovative pharmaceutical technologies
Focus on process optimization and operational excellence
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
Aseptic 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
