Senior Engineer

Senior Engineer role supporting Amgen's Drug Substance manufacturing facilities in Thousand Oaks, California. Responsibilities include leading equipment improvements, managing maintenance systems, troubleshooting production issues, and ensuring compliance with GMP and regulatory standards.

Responsibilities

• Lead identification and implementation of engineering improvements to facility equipment and systems
• Direct equipment maintenance operations and coordinate commissioning and system qualification activities
• Provide troubleshooting support for production issues through root cause analysis and corrective action implementation
• Support new product introductions via engineering assessments, equipment modifications, and engineering runs
• Manage CAPA processes, establish performance metrics, and ensure compliance with safety and regulatory standards

Requirements

• Doctorate degree, or Master's with 2+ years engineering experience, or Bachelor's with 4+ years
• Bachelor's in Biotechnology, Chemical, Mechanical, or Industrial Engineering preferred
• 6+ years relevant experience with 5+ years in biopharmaceutical manufacturing operations
• Working knowledge of GMP biopharmaceutical equipment including reactors, chromatography, filtration, and lyophilization systems
• Experience with regulated environment requirements: cGMP, OSHA, EPA, and quality systems
• Demonstrated ability in root cause analysis, statistical process control, and data-driven problem solving
• Strong technical writing, leadership, and cross-functional collaboration skills