Associate Manufacturing I
2 weeks ago
Role Description
Amgen discovers, develops and delivers innovative human therapeutics.
A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses.
With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
Perform solution and equipment preparation, raw material and single use parts dispensing for manufacturing processes in mammalian cell culture and purification processes.
Responsibilities
- Involve in handson execution of the plant operations and assist Manufacturing Associates in troubleshooting
- Monitor and analyze processing parameters for atypical trends and improvement opportunities
- Perform solution and equipment preparation
- Perform raw material and singe use parts staging and dispensing with additional logístical support responsibility
- Stage components for autoclaving and washing
- Perform filter integrity testing of sterilizing filters
- Perform environmental monitoring of classified manufacturing cleanroom
- Support inprocess testing of production samples, prior experience with analytical instrument will be a plus point
- Actively support continuous improvement initiatives
- Support Safety audits
- Adhere to any applicable EHS requirements
- 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)
- Basic statistical mathematical skills
- Ability to organize work and handle multiple priorities and meet deadlines
- Regulatory knowledge
- Understanding of analytical methods
- Some tasks performed consists 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
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