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

Responsibilities

• Lead continuous improvement initiatives focused on C&Q document preparation, digital execution, and process standardization
• Drive the optimization, governance, and adoption of Kneat and other digital validation tools across manufacturing sites
• Establish and maintain governance for C&Q digital tools, documentation standards, and best practices
• Develop standardized templates, workflows, and procedures to support digital commissioning and qualification
• Partner with Engineering, Validation, Quality, and Digital Technology teams to implement process and technology improvements
• Establish and monitor performance metrics and reporting to measure program effectiveness and documentation quality
• Provide training, coaching, and user support for digital tools used in C&Q execution
• Ensure all digital processes and documentation align with GMP requirements and data integrity standards

Requirements

• Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field
• 8–13 years of experience in GMP commissioning, qualification, validation, or technical operations within the biotech/pharma industry
• Proven experience implementing or supporting Kneat or other electronic validation/digital documentation platforms
• Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
• Proficiency in developing metrics, dashboards, or reporting tools using Power BI, Tableau, or Smartsheet
• Experience leading digital transformation or process standardization initiatives across engineering programs
• Strong leadership and stakeholder management skills with the ability to influence cross-functional teams

About the Company

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases. As a biotechnology pioneer, Amgen discovers, develops, and manufactures innovative medicines to help millions of patients worldwide.