Engineer - United States
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The DSC E&FR Plant Engineering team is responsible for the equipment used to scale up and produce Amgen’s supply of clinical drug substance and several recently launched commercial materials. The team is routinely introducing new processes, implementing improvements, and expanding the capabilities as new technologies emerge.
Provide operational support, troubleshooting, and optimization for assigned equipment
Support equipment maintenance activities to improve reliability
Apply engineering principles to the design and implementation of new equipment
Identify risks and implement risk reduction strategies
Lead and execute improvement efforts including cycle time reduction, efficiency gains, and yield enhancement opportunities
Lead or support technical root cause analysis, incident investigations, and troubleshooting on equipment
Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses
Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
Apply process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope and complexity
OR Bachelor’s degree and 2 years of Engineering experience
OR Associate’s degree and 6 years of Engineering experience
OR High school diploma / GED and 8 years of Engineering experience
Direct experience with regulated environments (e.g. FDA, cGMP, OSHA, EPA, etc.).
Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.
Direct experience in equipment engineering and troubleshooting with fermentors, bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
Experience with change control, nonconformance, corrective and preventative actions, and validation practices.
Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation.
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
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.