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

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

09 Jul, 26

Salary

0.0

Posted On

10 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commissioning and Qualification, Continuous Improvement, Digital Validation, Kneat, GMP, Process Standardization, Data Integrity, Risk-based Qualification, Engineering, Automation, Validation, Quality Assurance, Project Management, Operational Excellence, Technical Operations, Regulatory Compliance

Industry

Biotechnology Research

Description

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 (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 . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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Responsibilities

The Continuous Improvement Lead will drive digital enablement and process standardization for commissioning and qualification programs across engineering projects. This role involves governing digital tools like Kneat, monitoring performance metrics, and collaborating with cross-functional teams to ensure operational excellence and regulatory compliance.