Job Description

Career Category Manufacturing



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\xe2\x80\x99s 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\xe2\x80\x99s lives.

The associate manufacturing will be required to work on a rotational overnight shift to support daily production requirements. Operations, maintenance and analytical testing will be performed as required according to Standard Operating Procedures (SOPs) and Job Plans. The associate manufacturing will perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports. They will perform basic troubleshooting and assist in the review of documentation for assigned functions. The associate manufacturing may participate on cross-functional teams, and may identify, recommend and implement improvements related to routine functions.

Responsibilities:

Responsible for manufacturing synthetic API\xe2\x80\x99s and executing manufacturing duties

Support daily production requirements throughout the facility

Ensure that operations, maintenance and analytical testing be performed according to Standard Operating Procedures (SOPs) and Job Plans

Perform and monitor critical processes, execute routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports

Perform basic troubleshooting

Assist in the review of documentation for assigned functions

Responsible for owning NC/CAPAs and change controls

Responsible for identifying, recommending and implementing improvements related to routine functions

Ensure that operations are conducted in a safe and compliant manner

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Basic Qualifications

Bachelor\xe2\x80\x99s Degree in Science or Engineering and 2 years of directly related experience OR

Associate\xe2\x80\x99s 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

Possess minimum 0 - 2 years of relevant experience in the pharmaceutical or petrochemical industry. Fresh graduates will be considered.

Preferred Qualifications

Fluency in written and spoken English

Experience and basic troubleshooting skills with process equipment

Ability to understand, apply and evaluate basic chemistry, biology and physical principles

Ability to adhere to written procedures and safety guidelines

Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge

Ability to organize work, handle multiple priorities and meet deadlines

Demonstrated written and oral communication skills

Technical writing capabilities

Problem solving skills

Proficient presentation and facilitation skills

Mechanical ability/expertise

Understanding of analytical methods

Ability and willingness to work any shift in support of operations that may include 24/7 in a team environment

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Amgen