Senior Engineer - Plant Engineering
Amgen is seeking a Senior Plant Engineer at its main headquarters in Thousand Oaks, CA to join the Development Supply Chain (DSC) Facilities and Engineering (F&E) organization. This position will report to the Senior Manager of Engineering and will provide engineering support for the Biopharmaceutical Production facilities.
Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
- Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order
- Ensure necessary commissioning and qualification of systems is completed and interact with inspectors
- Monitor systems to identify performance risks and implement risk reduction strategies
- Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
- Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations
- Up to 10% domestic travel
Master's degree and 3 years of Engineering experience
Bachelor's degree and 5 years of Engineering experience
Associate's degree and 10 years of Engineering experience
High school diploma / GED and 12 years of Engineering experience
- Bachelor's degree in Chemical or Mechanical Engineering
- 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
- 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 troubleshooting 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.)
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
- Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
- Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time
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.