Top 3 Must Have Skill Sets: • Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation • Direct knowledge of design and troubles hooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. • Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Bachelor Engineering process mechanical degree and 5 years of experience
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The senior engineer works in partnership with the automation, maintenance, and manufacturing teams to develop and oversee the reliability of equipment while driving safety and quality compliance. The engineer will provide data to support business cases and long term strategy.
The Senior Engineer role will provide direct engineering technical support as follows: • Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment. • Be accountable for manufacturing equipment reliability • Suggest design modifications to address risks and design in quality and safety. • Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience