Amgen Senior Engineer in Singapore, Singapore

Role Description:

  • Process expert with Engineering background and experience in commercial production of mammalian cell derived proteins.

  • Applies expertise in the successful coordination of multiple, complex, non-routine activities including facility start up, process qualification through to regulatory approval, process performance monitoring, floor support, troubleshooting of unit operations and technology transfer of new processes.

  • Must have strong knowledge and understanding of cell culture and/or protein purification processes.

Education / Licenses

  • Advanced degree in Engineering, Science or related technological field

  • Doctorate degree & 2 year of directly related experience OR

  • Master's degree & 4 years of directly related experience OR

  • Bachelor's degree & 6 years of directly related experience

Relevant Experience

  • 6+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharamaceutical industries

  • At least 4 years experience with regulated environments (i.e. cGMP, OSHA, EPA) required.

Competencies / Skills

  • In depth cell culture and/or purification unit operations knowledge, including disposables technologies

  • Solid knowledge of protein chemistry related to commercial monoclonal antibody production

  • Experience in biotech equipment operation, design and control

  • Specialized equipment/process expertise in at least 3 separate unit operations for biologics manufacturing

  • Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production

  • Comprehensive understanding of commissioning, qualification and verification protocol execution requirements

  • Comprehensive experience in process monitoring

  • Good communication skills (technical writing and verbal communication/presentation)

  • Familiarity with documentation in a highly regulated environment

  • Interacts effectively with variety of communication and working styles

  • Working knowledge of financial analysis tools

  • Ability to independently determine when additional resources are required to solve problems

  • Demonstrated skills in the following areas:

  • Basic project management

  • Commissioning and Qualification

  • Scheduling

  • Collaboration

  • Completion and follow-up

  • Ability to provide solutions to a large variety of technical problems

  • Problem solving skills requiring the application of strong scientific and engineering theory and calculations