Sr Engineer I- Instrumentation

Amgen•Holly Springs, NC

About The Position

Join Amgen’s Facilities & Engineering group to partner with corporate engineering in designing, building, commissioning, and qualifying equipment and systems for drug substance production. Develop subject matter expertise to support operations after startup and serve as system owner for instrumentation and controls on site equipment, including manufacturing and laboratory equipment. Provide engineering support through design, construction, startup, commissioning, and qualification of new or modified instrumentation and control systems. Support daily operations, maintenance, and troubleshooting of plant and process instrumentation; monitor system performance and reduce operational risks and production downtime. Support investigations, root cause analysis, corrective and preventive actions, new product and technology introductions, and engineering improvements. The role may require support outside normal working hours, including nights, weekends, and holidays, to support 24/7 operations. Domestic and international travel may be required. The expected U.S. annual salary range, excluding Puerto Rico, is $115,494.60–$156,257.40. Actual salary varies based on relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan, subject to eligibility, with benefits, incentive programs, time-off plans, and career development opportunities.

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. A doctorate degree is also listed as a basic qualification.
Relevant 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 of field equipment and with 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 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, including two or more years in biopharmaceutical operations or manufacturing.
Experience with data analytics, root cause analysis, statistical process control, Six Sigma, or predictive maintenance.

Responsibilities

Own instrumentation and control systems for site equipment and support operations, including manufacturing and laboratory equipment.
Provide engineering support for 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 consumable items.
Partner with Automation Engineers, equipment System Owners, and maintenance technicians to identify and resolve field communication issues.
Evaluate supplier capabilities and assess technologies that may provide cost savings, efficiency, or other capabilities for manufacturing.
Identify, support, or lead engineering improvements and upgrades of small to medium scope and complexity for instrumentation, controls, or facility systems; develop a supporting business case when needed.
Support calibration program development, ensure spare-parts availability, and coordinate maintenance plans to keep systems accurate and operational.
Ensure systems are installed and operate safely in accordance with applicable environmental health and safety practices, rules, and regulations.
Ensure commissioning and qualification are completed in alignment with 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 leading or supporting technical root cause analysis and corrective/preventive action implementation.
Support new product and technology introductions through engineering assessments, equipment modifications, and engineering runs.
Advance condition-based and predictive maintenance practices, incorporating data analytics where applicable.
Own investigations of abnormal conditions through deviation and business processes.
Support operations outside normal working hours when required, including nights, weekends, and holidays.

Benefits

Retirement and Savings Plan with generous company contributions
Group medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
Stock-based long-term incentives
Award-winning time-off plans
Career development opportunities

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