Process Engineer

Katalyst CRO; Raleigh (NC); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Katalyst CRO is seeking an experienced Process Engineer Cartridge Filling to support a large-scale sterile pharmaceutical manufacturing expansion in Raleigh, NC. This consultant will provide technical expertise for cartridge filling operations, equipment implementation, startup, commissioning, qualification, and process optimization.

You will work cross-functionally with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to ensure cartridge filling processes meet

Qualifications

• Bachelor's degree in a related engineering discipline.
• 5+ years pharma manufacturing experience, preferably sterile injectable operations.
• Hands-on cartridge filling experience.
• Strong understanding of FDA cGMP regulations, EU GMP, Annex 1, and aseptic manufacturing principles.
• Excellent troubleshooting, communication, and technical writing skills.

Responsabilités

• Provide technical expertise for cartridge filling operations, equipment implementation, startup, commissioning, qualification, and process optimization.
• Collaborate with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering to meet production, quality, and regulatory objectives.
• Support startup of new manufacturing operations with direct cartridge filling line experience.

Connaissances

Cartridge filling

Sterile manufacturing

cGMP compliance

Technical writing

Troubleshooting

Cross-functional

Formation

Bachelor's degree in Mechanical Engineering

Outils

IQ/OQ

PQ

Description du poste

• 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.

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