Amgen Senior Associate Manufacturing in Thousand Oaks, California
The position is within the Cleaning Validation group and will perform validation tasks to support multi-product facility operation.
Execute validation tasks such as soiling, cleaning, and/or sanitizing bioprocess equipment. Perform validation testing such as taking swab and rinse samples, handling biological indicators, and operating process monitoring equipment. Operate cleaning equipment such as clean in place (CIP) skids, clean out of place (COP) baths and glassware washers, autoclaves, and steam in place systems.
Provide validation protocol execution training to manufacturing staff.
Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve cleaning and/or sterilization excursion events in a timely manner.
Follow GMP documents (SOPs) with strict adherence to safety and compliance
Work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and latex gloves when performing all work
Write validation protocols and reports in support of equipment commissioning, qualification, and change management.
Apply advanced process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support validation projects.
Manage Trackwise change control activities and support non-conformance and corrective action investigations.
Draft and revise documents (SOPs, Forms)
Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as dictated by the production schedule
- Bachelor's degree in Chemical Engineering, Industrial Engineering or Life Sciences and 2 years of manufacturing and operations experience
- Associate's degree in Chemical Engineering, Industrial Engineering or Life Sciences and 6 years of manufacturing and operations experience
- High school diploma / GED and 8 years of manufacturing and operations experience
Preferred Qualifications :
Degree in Chemical Engineering, Industrial Engineering or Life Sciences
Experience in GMP Tech Support roles, GMP operations, or process development
Technical knowledge of drug substance (upstream and/or downstream) processing and broad understanding of related disciplinary areas
Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical areas
Background in lean manufacturing methodologies and operational excellence
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.