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

ABOUT THE ROLE

Amgen is seekingaContinuousImprovement 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 ofKneatand other digital validation and documentation toolsto enhance C&Q execution, documentation quality, compliance, and inspection readiness across Engineering projects and manufacturing facilities. The ContinuousImprovement lead will drive improvements to processes, tools, and standards that enable efficient and scalable commissioning and qualification practices.

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

The role partners closely withEngineering, Automation, Validation, Quality, Manufacturing, Facilities, Digital Technology, and Project teamstoidentifyopportunities 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

• Establishandmaintaingovernance for C&Q digital tools, documentation standards, and continuous improvement initiatives across Engineering projects and sites

• Drive optimization, governance, and adoption ofKneatand other digital validation toolsacross Engineering projects and manufacturing sites

• Develop andmaintainstandardized templates, workflows, and best practices supporting digital commissioning and qualification execution

• Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Digital Technology teams toidentifyand implement process and technology improvements

• Establishandmonitorperformance metrics and reporting to measure efficiency, documentation quality, and program effectiveness

• Analyze operational data and program metrics toidentifyopportunities 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 forKneatand 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 supportingdigital transformation initiatives within Engineering, Validation, or Technical Operations environments

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

• Experience driving cross-site or global process standardization initiatives

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

• Experience implementing or supportingKneator 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 usingPowerBI, 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