Continuous Improvement Lead – Commissioning & Qualification (C&Q)

Amgen is seeking a Continuous Improvement Lead – Commissioning & Qualification (C&Q) to lead continuous improvement initiatives, establish and maintain governance, and drive optimization of digital validation tools across Engineering projects and sites.

Requirements

• Lead continuous improvement initiatives focused on C&Q document preparation, digital C&Q execution, and process standardization
• Establish and maintain governance for C&Q digital tools, documentation standards, and continuous improvement initiatives
• Drive optimization, governance, and adoption of Kneat and other digital validation tools
• Develop and maintain standardized templates, workflows, and best practices supporting digital commissioning and qualification execution
• Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Digital Technology teams to identify and implement process and technology improvements
• Establish and monitor performance metrics and reporting to measure efficiency, documentation quality, and program effectiveness
• Analyze operational data and program metrics to identify opportunities to improve efficiency, compliance, and execution consistency
• Lead implementation and adoption of standardized C&Q practices, templates, and procedures across Engineering projects and sites
• Provide training, coaching, and user support for Kneat and other digital tools used in C&Q execution
• Ensure digital processes and documentation practices align with GMP requirements, data integrity standards, and regulatory expectations
• Provide leadership and direction for continuous improvement initiatives across the Commissioning & Qualification Center of Excellence
• Foster a culture of continuous improvement, innovation, and operational excellence within the C&Q Center of Excellence