Process Analytical Engineer

Role: Process Analytical Engineer supporting cGMP laboratory systems at Amgen's North Carolina facility, focusing on qualification, calibration, maintenance, troubleshooting, and validation of analytical equipment for quality control. Objectives: ensure system reliability, compliance with regulatory standards, and operational readiness to support biopharmaceutical manufacturing. Responsibilities: own laboratory systems, develop and execute maintenance and calibration programs, support commissioning and validation activities, author validation documents, lead investigations, and collaborate with manufacturing and project teams to optimize equipment uptime and data integrity. Qualifications: Master’s degree or equivalent with experience in cGMP laboratory environments, analytical instrument validation, or process engineering; strong knowledge of biopharmaceutical testing methods and regulatory requirements for laboratory equipment. Preferred: Bachelor's in engineering or related field, hands-on experience with analytical instruments, and familiarity with electronic record integrity. High-value specifics include supporting biologics manufacturing at a high-tech biologics plant, ensuring compliance with GMP, Data Integrity, and validation standards, with a flexible schedule to support 24/7 operations and potential domestic/international travel.