Process Analytical Engineer
Amgen · Holly Springs, NC
The apply link worked recently (not employer-confirmed).
Role summary
This Process Analytical Engineer role supports Amgen's North Carolina manufacturing facility, focusing on qualification, calibration, and maintenance of laboratory systems for cGMP Quality Control operations. Responsibilities include troubleshooting analytical equipment, managing validation documentation, coordinating vendor support, and partnering with manufacturing teams to ensure system reliability and compliance. The position requires hands-on technical expertise and oversight of laboratory instrumentation systems.
What they're looking for
- Bachelor's degree in engineering, chemistry, or related scientific discipline
- Experience with laboratory analytical equipment qualification and validation
- Knowledge of cGMP regulations and regulatory compliance requirements
- Proficiency with computerized maintenance management systems like Maximo
- Strong troubleshooting and root cause analysis capabilities
- Experience with data integrity assessments and validation lifecycle documentation
What you'll be doing
- Plan, execute, and document qualification and calibration of cGMP quality control laboratory systems
- Perform hands-on troubleshooting and coordinate vendor support for analytical equipment repairs
- Author and approve validation lifecycle documents for computer-related systems
- Partner with manufacturing teams to resolve equipment issues and minimize operational downtime
- Lead development of calibration and maintenance programs to keep systems operational
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.