Continuous Improvement Lead – Commissioning & Qualification (c&q)
Amgen Inc
Commissioning and qualification experience
Digital validation tool implementation
Gmp compliance and data integrity
This role leads continuous improvement initiatives to strengthen digital enablement and process standardization for Engineering commissioning and qualification programs
Job Summary
This role leads continuous improvement initiatives to strengthen digital enablement and process standardization for Engineering commissioning and qualification programs.
The incumbent will drive the adoption of digital tools like Kneat to enhance execution efficiency, documentation quality, and inspection readiness across manufacturing facilities.
Candidates must partner closely with Engineering, Quality, and Digital Technology teams to establish governance for C&Q standards and ensure alignment with GMP requirements.
Matching Summary
This role leads continuous improvement initiatives to strengthen digital enablement and process standardization for Engineering commissioning and qualification programs.
Skills & Requirements
Must-have
Commissioning and Qualification experience
Digital validation tool implementation
GMP compliance and data integrity
Process standardization leadership
Cross-functional stakeholder management
Nice-to-have
Power BI or Tableau analytics skills
Experience with Kneat platform
Risk-based qualification methodologies
Global process standardization background
Training and coaching capabilities
Key Requirements
8-13 years of relevant work experience
Bachelor's or Master's degree required
Experience in regulated pharmaceutical or biotechnology environments