Career Category

Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

• In this vital 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.

Basic Qualifications and Experience:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Information Systems, or a related technical field.

• 8–13 years of experience in GMP commissioning, qualification, validation, engineering, technical operations, or continuous improvement within the pharmaceutical or biotechnology industry.

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

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

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

Functional Skills (Must Have):

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

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

• Experience driving cross-site or global process standardization initiatives.

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

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

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

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

Good-to-Have Skills:

• Familiarity with digital validation lifecycle management tools and automation platforms.

• Experience supporting large-scale Engineering capital projects or global operational excellence programs.

• Exposure to data analytics, reporting automation, and digital workflow optimization initiatives.

• Knowledge of continuous improvement methodologies and operational excellence frameworks.

• Experience supporting inspection readiness initiatives and regulatory audits within GMP environments.

Soft Skills:

• Strong leadership and stakeholder management skills.

• Effective verbal and written communication skills.

• Ability to collaborate effectively across global cross-functional teams.

• Strong analytical, problem-solving, and decision-making capabilities.

• Strong organizational and time management skills with the ability to manage competing priorities.

• Ability to foster a culture of continuous improvement, innovation, and operational excellence.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.