Sr Engineer I- Instrumentation

Amgen•Holly Springs, NC

3d•$115,495 - $156,257

About The Position

Amgen is seeking a Senior Instrumentation Engineer to join its Facilities & Engineering group and partner with corporate engineering to design, build, commission, and qualify equipment and systems for drug substance production. The role develops subject matter expertise to support operations after startup and provides system ownership for instrumentation and controls across site equipment, including manufacturing and laboratory equipment. The engineer supports the full lifecycle of new and modified systems, from design and selection through construction, startup, commissioning, qualification, operation, and maintenance. The role also supports production troubleshooting, improvement projects, new product and technology introductions, and reliability initiatives. Work may require engineering coverage outside normal hours to support 24/7 operations.

Requirements

High school diploma or GED and 10 years of Engineering/I&C experience; or an associate degree and 8 years; or a bachelor’s degree and 4 years; or a master’s degree and 2 years; or a doctorate degree.
Relevant work experience in a biopharmaceutical operations or manufacturing environment, including 2 or more years in that environment.
Hands-on experience designing and troubleshooting instrumentation and controls for process equipment and utility systems in a GMP biopharmaceutical production facility.
Experience with field wiring and communications for field equipment in relation to process control systems such as DeltaV, Allen Bradley PLC, and/or Building Automation Systems.
Ability to analyze problems and develop and propose engineering solutions using scientific, data-driven techniques and analyses.
Experience in a regulated environment such as cGMP, OSHA, or EPA, and familiarity with GMP quality systems and processes, including change control, non-conformances, corrective and preventive actions, and qualification/validation.
Experience applying engineering principles to system modifications, new process introductions, and capital projects.
Understanding of capital project processes in a GMP biopharmaceutical production facility, including procurement, construction, startup, and validation.
Understanding of safety requirements in a GMP biopharmaceutical production facility.
Ability to work independently, stay organized, multitask in project environments, and communicate, facilitate, and collaborate effectively.
Strong leadership, technical writing, communication, and presentation skills.
Flexibility to support 24/7 operations, including occasional after-hours engineering coverage.
Ability and willingness to travel domestically and internationally.

Nice To Haves

Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering.
Four or more years of relevant work experience.
Experience using data analytics, root cause analysis, statistical process control, Six Sigma, or predictive maintenance approaches.

Responsibilities

Provide system ownership for instrumentation and control of equipment and support site manufacturing and laboratory operations.
Support design, construction, startup, commissioning, and qualification of instrumentation and controls for new or modified systems.
Lead or collaborate on the design, development, and selection of systems, instruments, calibration capabilities, and consumables.
Partner with Automation Engineers, equipment System Owners, and maintenance technicians to identify and resolve field communication issues.
Evaluate suppliers and new technologies for potential cost savings, efficiency, or other manufacturing capabilities.
Identify, support, or lead small- to medium-scope engineering improvements or upgrades to instrumentation, controls, or facility systems, and develop project cases when required.
Support calibration program development, spare-parts availability, and maintenance planning to keep systems in accurate working order.
Ensure systems are safely installed and operated in accordance with applicable environmental health and safety practices, rules, and regulations.
Ensure system commissioning and qualification meet site GMP requirements and interact with regulatory inspectors as needed.
Apply engineering principles to daily operation, maintenance, and troubleshooting of plant and process instrumentation systems.
Monitor systems for performance risks and implement risk-reduction strategies.
Provide troubleshooting support to reduce production downtime, including technical root cause analysis and corrective and preventive action implementation; support may be needed outside normal working hours, including nights, weekends, and holidays.
Support new product and technology introductions through engineering assessments, equipment modifications, and engineering runs.
Advance condition-based and predictive maintenance practices using data analytics where applicable.
Own investigations of abnormal conditions through deviation and business processes.