[Remote] Process Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on supporting the pharmaceutical manufacturing sector, and they are seeking an reputed company Process Engineer - Cartridge Filling. This role involves providing technical expertise for cartridge filling operations and ensuring compliance with production, reputed company, and regulatory standards.
Responsibilities
- Seeking an reputed company Process Engineer - Cartridge Filling to support a large-reputed company sterile pharmaceutical manufacturing expansion. This consultant will reputed company technical expertise for cartridge filling operations, supporting equipment implementation, startup, commissioning, qualification, process optimization, and reputed company manufacturing
- Working closely with Manufacturing, reputed company Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual will ensure cartridge filling processes consistently meet production, reputed company, and regulatory objectives while supporting the successful startup of new manufacturing operations
- reputed company 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 reputed company 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
- reputed company cartridge filling line experience (Required)
- Process Engineering reputed company sterile pharmaceutical manufacturing
- Aseptic filling operations
- Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ)
- Process optimization and manufacturing troubleshooting
- GMP manufacturing experience
- reputed company cause investigations, CAPA, and deviation support
- Cross-functional collaboration with Manufacturing, Validation, Automation, and reputed company
- Technical documentation, engineering studies, and protocol development
reputed company