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

ABOUT THE ROLE 

Amgen is seeking a Continuous Improvement Lead – Commissioning & Qualification (C&Q) to join the Engineering Commissioning & Qualification (C&Q) Center of Excellence (CoE). In this role, you will lead continuous improvement initiatives that strengthen digital enablement, process standardization, and operational excellence supporting Engineering commissioning and qualification programs. 

This role focuses on advancing the use of Kneat and other digital validation and documentation tools to enhance C&Q execution, documentation quality, compliance, and inspection readiness across Engineering projects and manufacturing facilities. The Continuous Improvement lead will drive improvements to processes, tools, and standards that enable efficient and scalable commissioning and qualification practices. 

This role helps establish and govern standardized C&Q processes, digital tools, and best practices that support consistent execution across Engineering projects and sites. 

The role partners closely with Engineering, Automation, Validation, Quality, Manufacturing, Facilities, Digital Technology, and Project teams to identify opportunities for improvement, implement digital solutions, and standardize C&Q practices across Amgen’s operations. 

ROLES & RESPONSIBILITIES 

• 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 across Engineering projects and sites 

• Drive optimization, governance, and adoption of Kneat and other digital validation tools across Engineering projects and manufacturing sites 

• 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 

PREFERRED/GOOD TO HAVE QUALIFICATIONS & SKILLS 

• Bachelors or Masters degree

• 8-13 Years of work experience in the relevant field

• Experience implementing or supporting digital transformation initiatives within Engineering, Validation, or Technical Operations environments 

• Knowledge of ASTM E2500, ISPE guidance, or modern risk-based commissioning and qualification approaches 

• Experience driving cross-site or global process standardization initiatives 

• Experience in GMP commissioning, qualification, validation, or technical operations in a regulated pharmaceutical or biotechnology environment 

• Experience implementing or supporting Kneat or other electronic validation / digital documentation platforms 

• Experience leading continuous improvement, digital enablement, or process standardization initiatives across engineering or technical operations programs 

• Experience developing metrics, dashboards, or reporting tools using Power BI, Tableau, Smartsheet, or similar analytics platforms 

• Strong understanding of risk-based qualification methodologies and lifecycle validation approaches 

• Strong knowledge of GMP documentation practices, data integrity expectations, and inspection readiness principles 

• Experience developing or implementing standardized templates, processes, and governance practices supporting commissioning and qualification programs 

• Experience collaborating across Engineering, Validation, Quality, Manufacturing, Facilities, and Digital Technology organizations 

• Experience supporting commissioning and qualification activities in one or more of the following areas: drug substance, drug product, packaging, or facilities and utilities 

• Strong leadership, communication, and stakeholder management skills with the ability to influence cross-functional teams and drive adoption of new processes or tools