Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is a pharmaceutical company seeking a Process Engineer to support a large-scale sterile pharmaceutical manufacturing expansion. The role involves providing technical expertise for cartridge filling operations, including equipment implementation, startup, commissioning, qualification, and process optimization, while ensuring compliance with production, quality, and regulatory standards.
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
Skills
- 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
- 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
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