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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 an Associate Manufacturing I in Amgen Singapore Manufacturing.
Job Responsibility
Support daily production requirements throughout the facility
Operations, maintenance and analytical testing will be performed according to Standard Operating Procedures (SOPs) and Job Plans, as required
Perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports
Perform basic troubleshooting and assist in the review of documentation for assigned functions
May participate on cross-functional teams
Responsible for owning NC/CAPAs
May identify, recommend and implement improvements related to routine functions
Ability to apply ergonomics principles to the work environment and maintain focus during repetitious tasks over the course of a shift
Some tasks performed consist of occasional strenuous, repetitive movements involving the following bending, hand/wrist twisting and reaching out for height on a daily basis, as well as standing for the long hours on the production floor in accordance to shift duration
Ability to perform manual lifting, carrying, pushing and/or pulling items with an average weight of <12kg on production floor with or without the assistant of mechanical aid
Requirements
Bachelor’s Degree in Science or Engineering and 2 years of directly related experience OR Associate’s Degree in Science or Engineering and 4 years of directly related experience OR High School Diploma in Science or Engineering / GED and 6 years of directly related experience
1 year of experience in regulated environment
Experience and basic troubleshooting skills with laboratory and process equipment
Experience with Emerson DeltaV, OSI PI, LIMS, TrackWise
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Regulatory knowledge
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to interact with inspectors (internal and external)
Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
Basic statistical mathematical skills
Ability to organize work, handle multiple priorities and meet deadlines
Technical writing capabilities
Proficient presentation and facilitation skills
Detail oriented as well as flexible and adaptable to changing priorities and requirements
Ability to perform computer operations, such as ability to navigate in MS Office and complete Computer Based Training (CBT)
Mechanical ability/expertise
Understanding of analytical methods
Ability and willingness to work any shift in support of operations that may include 24/7
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