Associate Mfg I
4 days ago
Career Category
Manufacturing
**Job Description**:
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.
**Responsibilities**:
- Involve in hands-on 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 in-process 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
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’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
Preferred Qualifications
- NTC/ITC/Diploma in Chemical, Pharmaceutical, Life Sciences or Bio-processing related disciplines
- Possess minimum 0 - 2 years of relevant experience in the biotechnology, pharmaceutical or petrochemical industry. Fresh graduates will be considered.
- Knowledge of plant and unit operations (autoclave, parts washers, process equipment), good problem-solving skills
- Proficiency in reading and writing English
- Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation, prior experience and demonstration of cGMP knowledge is a plus
- Excellent self-motivated team player with hands-on attitude and good communication skills
- Experience with Emerson DeltaV, LIMS, TrackWise
- Ability and willingness to work any shift in support of operations that may include 24/7
- Mechanical ability/expertise
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