Process Analytical Engineer: cGMP Lab Systems & Validation

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 150,000; Full time

Job summary

Amgen in North Carolina is seeking a Process Analytial Engineer to join the Facilities & Engineering group. The role focuses on planning, executing, and documenting qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control facilities.

You will troubleshoot, coordinate vendor support, and manage calibration and requalification activities in CMMS Maximo, while supporting manufacturing to improve uptime and reliability.

Qualifications

• Master's degree in engineering or related field required.
• Experience with cGMP laboratory instrument validation.
• Knowledge of analytical instrumentation and calibration processes.

Responsibilities

• Own and manage qualification, calibration, and routine maintenance of laboratory systems.
• Coordinate with manufacturing teams to improve system reliability and uptime.
• Write and review validation life cycle documents and data integrity efforts.
• Support audit readiness and regulation inspections.

Skills

Analytical instrument validation

cGMP Knowledge

Root cause analysis

Data integrity

CMMS (Maximo)

Project coordination

Education

Master's degree in engineering or related field

Tools

Maximo CMMS

Laboratory equipment

Job description

Amgen in North Carolina is seeking a Process Analytial Engineer to join the Facilities & Engineering group. The role focuses on planning, executing, and documenting qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control facilities.

You will troubleshoot, coordinate vendor support, and manage calibration and requalification activities in CMMS Maximo, while supporting manufacturing to improve uptime and reliability.