Process Analytical Engineer

Amgen Inc

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.

Responsibilities

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

Requirements

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

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Vacancy posted a month ago

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