BASIC QUALIFICATIONS:

• High school diploma / GED and 8 years of Engineering/Maintenance experience OR
• Associate’s degree and 6 years of Engineering/Maintenance experience OR
• Bachelor’s degree and 5 years of Engineering/Maintenance experience OR
• Master’s degree

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in Chemical or Mechanical engineering
• 6+ years of relevant work experience with 5+ years’ experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, Clean Air generation and distribution, and CIP; and as well as other Plant Utility equipment needed to support these processes such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
• Experience with equipment and facility control systems operation, logic, and troubleshooting.
• 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
• Strong leadership, technical writing, communication/presentation skills and the ability to work with minimum direction.
• Proven interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
• Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
• Ability to function within cross-functional teams and embrace a team-based environment.
• 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, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
• Great teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

Let’s do this. Let’s change the world. In this role the Engineer reports to the Senior Manager of the Process Engineering group. The position is responsible for providing daily Engineering support at the Amgen North Carolina site.

• Provide system ownership for process systems and equipment supporting operations at the site.
• Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
• Develop equipment/instrument maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as vital to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
• Ensure vital commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as vital.
• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
• 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.
• Advance the use of condition based and predictive maintenance practices by incorporating sophisticated data analytics where applicable.
• Own investigations of abnormal conditions through Deviation and business processes.
• Develop, coordinate, analyze, and present results for operational issues and engineering projects
• Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.
• Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements
• Communicating with supervisor and support staff, highlighting issues and proposing solutions.
• Work in a small group of engineers and/or technicians on an ongoing or project basis.
• Provide technical support and issue resolution with 24x7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays).
• Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
• Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing