Amgen Manufacturing Specialist in Singapore, Singapore
This role is within the manufacturing organization of Amgen Singapore Manufacturing. The Mfg Specialist is a key role to support the manufacturing shift in successful execution. We offer a broad exposure to all key aspect of GMP manufacturing as well as tactical and strategic teamwork within the extended manufacturing network. Areas of scope and responsibilities include:
Change control ownership
Nonconformance investigation ownership.
Troubleshooting of Non-Conformances and working with Quality, F&E, EH&S, P&PD, P&PE etc to address CAPAs.
Work very closely with Regulatory and Quality partners to manage change control processes and respond to regulatory questions and/or audit findings.
Operations Excellence plant core team member who champions OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
Technical expert who helps introduce advanced process technologies and approaches - generally described as 'Manufacturing of the Future' - into the plant.
- Doctorate degree
- Master's degree & 3 years of directly related experience
- Bachelor's degree & 5 years of directly related experience
- Associate's degree & 10 years of directly related experience
- High school diploma / GED & 12 years of directly related experience
Master's degree in Chemical Engineering or Life Sciences
5+ years experience in GMP Tech Support roles, GMP operations or process
- Extensive technical knowledge of upstream or downstream processing and
broad understanding of related disciplinary areas
Ability to design and execute a technical study with minimal guidance
Ability to organize, analyze, and interpret technical data through trend analysis,
forecasting, modeling, etc.
- Ability to effectively communicate complex technical information with internal and
external colleagues of varying organizational levels in both presentation and
technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical areas
Understands the core functional business processes and their role in Amgen's