Process Engineer

Katalyst CRO; Frederick (MD); Sur place; USD 95 000 - 135 000; Plein temps

Résumé du poste

Katalyst CRO is seeking an experienced Process Engineer for cartridge filling in a large-scale sterile pharmaceutical expansion. The consultant will lead technical efforts in equipment implementation, startup, commissioning, qualification, and process optimization to ensure compliant, efficient production.

Collaborating with QA, Validation, Automation, Maintenance, and Project Engineering, you will drive startup success for new manufacturing operations and maintain exceptional process control in

Qualifications

• Bachelor's degree in Mechanical, Chemical, Biomedical, Manufacturing, or related engineering discipline.
• 5+ years of pharmaceutical manufacturing experience, preferably sterile injectable operations.
• Hands-on cartridge filling experience is required.
• Strong knowledge of FDA cGMP, EU GMP, Annex 1, and aseptic manufacturing.

Responsabilités

• Provide technical expertise for cartridge filling operations during expansion.
• Support equipment implementation, startup, commissioning, qualification, and process optimization.
• Work with QA, Validation, Automation, and Manufacturing to meet regulatory objectives and startup goals.

Connaissances

Cartridge filling

Sterile manufacturing

Aseptic processing

Equipment startup & qualification

Process optimization

GMP compliance

Root cause investigations

Cross-functional collaboration

Technical documentation

Formation

Bachelor's degree in Mechanical Engineering or related field

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