Amgen is seeking an Engineer - System Owner AML14 to provide technical support and oversight for manufacturing systems, particularly syringe lines, to enhance performance and compliance.
Requirements
- Master’s degree in Engineering
- Bachelor’s degree in Engineering & 2 years of manufacturing and/or engineering experience
- Experience in a GMP-regulated environment within pharmaceutical, biotech, or medical device industries
- Background in process characterization, validation, and monitoring
- Basic working knowledge of process equipment design and performance evaluation
- Familiarity with statistical data analysis and Design of Experiments (DOE)
Responsibilities
- Support daily operations and resolve equipment or process issues to meet production goals
- Organize, analyze, and present findings from operational or engineering investigations
- Provide technical solutions to moderately complex problems
- Monitor and support manufacturing using Statistical Process Control (SPC)
- Conduct product and process impact assessments for non-conformances, including defining CAPAs
- Apply standard engineering techniques and procedures to improve equipment reliability and performance
- Act as technical expert for assigned systems or equipment
Other
- Willingness to work non-standard shifts (10-12 hour shifts, nights, weekends, holidays)
- Ability to apply engineering principles to solve technical problems in a production environment
- Demonstrated problem-solving and applied engineering skills
- Experience writing technical reports
- Strong communication skills in Spanish and English (verbal and written)
- Master’s degree in Engineering
- Bachelor’s degree in Engineering & 2 years of manufacturing and/or engineering experience
