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.
Under minimal supervision, an Associate Manufacturing will routinely assist in performing complex to critical processes according to Standard Operating Procedures in the Manufacturing area.
Individual will be responsible for the manufacturing of sterile products. Individual will perform a variety of operations involving aseptic filling, primarily operation of automated fill equipment inside the aseptic environment.
- Revise/Modify GMP documentation including batch records and/or SOPs
- Perform operations during fills by following proper procedures
- Detailed and accurate documentation in batch production records
- Operation of the fill/stoppering equipment to dispense sterile product into glass or plastic containers
- Perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques
- Position may assist in training of co-workers
- Determine availability of components and assign accordingly
- Environmental monitoring of the aseptic environment during each fill and after each fill
- Position will perform non-standard shifts, evenings and/or weekends.
- Operation of the continuous particulate monitoring systems during each fill
- High levels of housekeeping to conform to cGMP standards
- Associate’s degree and 4 years of Manufacturing & Operations related experience
- Demonstrate project management skills, presentation skills, and be able to independently collaborate with outside resources
- Exposure to aseptic fill, lyophilization, bio-pharma manufacturing equipment, trouble shooting and moving machinery
- Light to moderate lifting and carrying of 15-44 lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses
Qualification & Experience:
- Bachelors Degree in Mechanical Engineering, Biomedical engineering, Life Sciences or Technology
- Bachelor’s degree
- Experience in maneuvering a highly dynamic process with multi-variable inputs
- High School diploma/GED and 6 years of Manufacturing & Operations related experience
Vacancy Type: Full Time
Job Functions: Manufacturing
Job Location: Thousand Oaks, CA, US
Application Deadline: N/A