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Process Development Engineer at Amgen Singapore Manufacturing. Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Process Development Engineer in Amgen Singapore Manufacturing.
Job Responsibility:
Applies expertise in the successful coordination of multiple, complex, non-routine activities including tech transfer process qualification, process performance monitoring, floor support, troubleshooting of unit operations
Support/lead complicated investigations, providing concise communications to teams and leadership
Compile and analyze process data using tools such as excel, JMP, SIMCA to inform future decision-making and take predictive action
Author technical protocols, technical assessments, and product impact assessments
Verify data in technical reports, spreadsheets, and regulatory filings
Utilize strong written and verbal communication skills in technical writing and presentations
Requirements:
Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience
3+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
At least 2 years’ experience with regulated environments (i.e. cGMP) required
In depth cell culture process knowledge, including single-use technologies and harvest technologies
Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Possess basic understanding of regulatory and cGMP requirements
Able to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
Able to escalate relevant issues to project lead and line management
Independently motivated but also work well in team environment
Strong communication skills (technical writing and verbal communication/presentation)
Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
What we offer:
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
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