Process Analytical Engineer — Lab Systems & Calibration

Amgen; Holly Springs (NC); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen NC facility seeks a Process Analytical Engineer to manage qualification, calibration, and routine maintenance of laboratory systems. You will troubleshoot, coordinate vendor support, and drive data integrity within CMMS Maximo while supporting manufacturing operations for uptime.

This role requires strong regulatory knowledge and hands-on lab engineering experience. Preferred candidates will have an engineering degree with cgmp instrumentation familiarity and be able to work across

Qualifications

• Master’s or bachelor’s with cgmp lab and/or process engineer experience.
• Integrity with data, equipment qualification, calibration and QC.
• Knowledge of regulatory requirements and audit support.

Responsibilities

• Own qualification, calibration, maintenance for lab systems.
• Coordinate vendor support and repairs; track via CMMS (Maximo).
• Support manufacturing to improve uptime and reliability.
• Develop validation lifecycle documents and data integrity.
• Lead change controls and coordinate regulatory readiness.

Skills

System ownership

Calibration

Maintenance

Data integrity

Regulatory compliance

Cross-functional

Root cause analysis

Troubleshooting

CMMS Maximo

Vendor coordination

Education

Master’s degree in engineering

Bachelor’s degree + 2y cgmp experience

Associate’s degree + 6y cgmp experience

High school diploma + 8y cgmp experience

Tools

Maximo

Job description

Amgen NC facility seeks a Process Analytical Engineer to manage qualification, calibration, and routine maintenance of laboratory systems. You will troubleshoot, coordinate vendor support, and drive data integrity within CMMS Maximo while supporting manufacturing operations for uptime.

This role requires strong regulatory knowledge and hands-on lab engineering experience. Preferred candidates will have an engineering degree with cgmp instrumentation familiarity and be able to work across