Engineer - Plant Engineering

Job Summary

Amgen is seeking an Engineer at its main headquarters in Thousand Oaks, CA to join the GMP Facilities and Engineering (F&E) Plant Engineering Team in the Development Supply Chain (DSC) organization. This position will report to the Senior Manager Engineering and will serve as the plant engineer and system owner for process equipment in a state of the art bulk biopharmaceutical manufacturing facility.

The 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.

Responsibilities

• 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

Basic Qualifications

Master's degree

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

Preferred Qualifications

• 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 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.
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.

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