Bachelor's degree in a relevant engineering discipline
5+ years in pharmaceutical manufacturing, especially sterile injectables
Hands-on experience with cartridge filling operations
Strong knowledge of FDA and EU GMP regulations
Proven record in equipment validation and manufacturing startups
Excellent problem-solving and technical writing abilities
Responsibilities
Support technical aspects of cartridge filling for a manufacturing expansion
Drive successful startup, commissioning, and qualification of equipment
Collaborate with teams across Manufacturing, QA, and Automation
Ensure production aligns with quality and regulatory standards
Focus on optimizing cartridge filling processes through continuous improvement
Benefits
Opportunity to work on a large-scale sterile manufacturing project
Access to a collaborative cross-functional team environment
Involvement in cutting-edge pharmaceutical technology
Enhance your troubleshooting and technical documentation skills
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
