Process Analytical Engineer

Job title: Process Analytical Engineer

About the Role In this role, you will join Amgen’s Facilities & Engineering group and be responsible for planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen North Carolina (ANC). This role includes hands-on troubleshooting and root cause analysis for analytical and laboratory systems, coordination of vendor support and repairs, execution and tracking of calibration, maintenance, and requalification activities through the CMMS Maximo, and direct support for manufacturing operations to improve equipment uptime and reliability. You will also author, own, and approve Validation Life Cycle documents for computer-related systems, including responsibility for Data Integrity testing and business administration of laboratory computer-related systems. Support commissioning, qualification, validation, and system lifecycle documentation to maintain compliance and operational readiness. Partner closely with manufacturing teams to resolve issues, improve system reliability, and minimize operational downtime.

What You'll Do

• Plan, execute, and document qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control facilities at Amgen North Carolina (ANC).
• Perform hands-on troubleshooting and root cause analysis for analytical and laboratory systems; coordinate vendor support and repairs; execute and track calibration, maintenance, and requalification activities through the Computerized Maintenance Management System (CMMS) Maximo; provide direct support for manufacturing operations to improve equipment uptime and reliability.
• Author, own, and approve Validation Life Cycle documents for computer-related systems; manage Data Integrity testing and business administration of laboratory computer-related systems.
• Support commissioning, qualification, validation, and system lifecycle documentation to maintain compliance and operational readiness.
• Partner with manufacturing teams to resolve issues, improve system reliability, and minimize operational downtime.
• Own system ownership, develop calibration/maintenance programs, ensure spare parts availability, schedule repairs, and coordinate maintenance to keep systems in proper working order.
• Participate in technical project teams as a subject matter expert on instrument validation regulations and procedures.
• Evaluate current and potential suppliers and technologies for cost savings, throughput, or other capabilities.
• Write or contribute to equipment operating procedures and manuals; design and deliver training for manufacturing and other staff.
• Own and manage change controls; provide periodic management updates; conduct periodic reviews of instrument validation as part of the validation life cycle.
• Support Data Integrity assessments for lab systems and assist audit interactions; ensure alignment with GMP requirements.
• Provide cross-functional support, drive continuous improvement, and assist regulatory interactions as needed.

What We're Looking For

• Experience planning, executing, and documenting qualification, calibration, and maintenance of laboratory systems in a cGMP Quality Control environment.
• Proficiency with CMMS (Maximo) for calibration, maintenance, and tracking activities.
• Ability to author, own, and manage Validation Life Cycle documentation; experience with Data Integrity and laboratory system administration.
• Hands-on troubleshooting and root cause analysis; strong collaboration with manufacturing and QA teams.
• Knowledge of regulatory requirements for equipment qualification and calibration; familiarity with instrument validation regulations and procedures.
• Strong communication skills; ability to prepare management updates and present to senior leadership.