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

Career Category Engineering Job Description 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 ( C oE ) . 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   .