Amgen Specialist Manufacturing in Singapore, Singapore

This responsible system owner (RSO) 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: Equipment owner for new product introductions (NPI) into the GMP plant, managing the entire established equipment reliability business process and improving it over time, Change control ownership and nonconformance investigation ownership. Troubleshooting of equipment 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. Equipment technical expert who helps introduce advanced single use technologies and approaches - generally described as 'Manufacturing of the Future' - into the plant.

Basic Qualifications

  • Doctorate degree

OR

  • Master's degree & 3 years of directly related experience

OR

  • Bachelor's degree & 5 years of directly related experience

OR

  • Associate's degree & 10 years of directly related experience

OR

  • High school diploma / GED & 12 years of directly related experience

Preferred Qualifications

  • Master's degree in Chemical Engineering or Life Sciences

  • 5+ years experience in GMP Tech Support roles, GMP operations or process

development.

  • Extensive technical knowledge of upstream or downstream process equipment 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

commercialization program