Process Analytical Engineer

About the role

Amgen is hiring a Process Analytical Engineer to join its Facilities & Engineering group at the Amgen North Carolina (ANC) site. The role covers planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems in the cGMP Quality Control lab, including troubleshooting, vendor coordination and support for manufacturing operations. It sits in the context of the new FleX batch facility, which combines disposable technologies with stainless steel equipment and integrates Industry 4.0 and sustainability features.

Key responsibilities

• Plan, execute and document qualification, calibration and routine maintenance of laboratory systems, and troubleshoot and perform root cause analysis on analytical and laboratory systems.
• Coordinate vendor support and repairs, and track calibration, maintenance and requalification activities in the CMMS Maximo.
• Author, own and approve Validation Life Cycle documents for computer-related systems, including Data Integrity testing and business administration of those systems.
• Support commissioning, qualification, validation and system lifecycle documentation, and partner with manufacturing teams to improve system reliability and reduce downtime.
• Serve as System Owner and Business Administrator for analytical equipment, develop equipment specifications, and lead or contribute to calibration and maintenance programs and spare parts availability.
• Take part in technical project teams as a subject matter expert on instrument validation regulations, evaluate suppliers and new technologies, and write operating procedures and manuals.
• Train manufacturing and department staff, project manage change controls, and prepare periodic management updates.
• Contribute to Data Integrity assessments, support audit interactions, and lead investigations of deviations and abnormal conditions.
• Provide troubleshooting support, including nights, weekends and holidays, and advance condition-based and predictive maintenance using data analytics.

Required profile

• Master's degree, or Bachelor's degree plus 2 years of cGMP laboratory, analytical instrument validation and/or Process Engineer experience, or Associate's degree plus 6 years of such experience, or high school diploma / GED plus 8 years of such experience.
• Preferred: Bachelor's degree in engineering or a related technical field, and laboratory experience in a cGMP environment including analytical instrument validation.
• Preferred: ability to provide on-call coverage nights and weekends on a rotating basis.

Required skills

• Knowledge of cGMP laboratory equipment validation and electronic record integrity requirements.
• Knowledge of methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
• Demonstrated success managing an equipment qualification or maintenance program.
• Strong written and verbal communication skills.