Amgen Senior Engineer in Singapore, Singapore
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
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
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