Process Analytical Engineer: Lab Systems & Validation

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Amgen, a leader in biopharmaceuticals, is seeking a Process Analytical Engineer to join the North Carolina facility. You will plan, execute, and document qualification and maintenance of laboratory systems, troubleshoot analytical equipment, and support validation activities for cGMP compliance.

This role partners with manufacturing to improve equipment uptime and ensure regulatory readiness, including data integrity and system lifecycle documentation across projects and sites.

Qualifications

• Masters degree required or equivalent combination of education and experience.
• Bachelor's degree in engineering or related technical field or equivalent.
• Associates degree with relevant cGMP lab experience or high school with extensive experience may be considered.

Responsibilities

• Plan, execute, and document qualification, calibration, and routine maintenance of laboratory systems for cGMP QC facilities.
• Perform troubleshooting and root cause analysis for analytical equipment and coordinate vendor support.
• Manage calibration, maintenance, and requalification activities in Maximo CMMS.
• Develop and approve validation life cycle documents for computer-related systems, including data integrity testing.
• Support commissioning and system lifecycle documentation to maintain compliance and readiness.
• Collaborate with manufacturing to improve equipment uptime and reliability.

Skills

cGMP laboratory experience

Analytical instrument validation

Process engineering experience

Education

Master's degree

Bachelor's degree in engineering or related technical field

Associates degree

High school diploma / GED

Job description

Amgen, a leader in biopharmaceuticals, is seeking a Process Analytical Engineer to join the North Carolina facility. You will plan, execute, and document qualification and maintenance of laboratory systems, troubleshoot analytical equipment, and support validation activities for cGMP compliance.

This role partners with manufacturing to improve equipment uptime and ensure regulatory readiness, including data integrity and system lifecycle documentation across projects and sites.