Continuous Improvement Lead – Commissioning & Qualification (c&q)

Amgen Australia Pty Ltd

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 within the Engineering Commissioning & Qualification Center of Excellence

Job Summary

  • This role leads continuous improvement initiatives to strengthen digital enablement and process standardization within the Engineering Commissioning & Qualification Center of Excellence.
  • The incumbent will drive the optimization and adoption of Kneat and other digital validation tools to enhance execution quality and inspection readiness across manufacturing facilities.
  • Candidates must partner with cross-functional teams including Quality, Manufacturing, and Digital Technology to establish governance for C&Q digital tools and documentation standards.

Matching Summary

This role leads continuous improvement initiatives to strengthen digital enablement and process standardization within the Engineering Commissioning & Qualification Center of Excellence.

Skills & Requirements

Must-have

  • Commissioning and Qualification experience
  • Digital validation tool implementation
  • GMP compliance and data integrity
  • Process standardization leadership
  • Cross-functional stakeholder collaboration

Nice-to-have

  • Power BI or Tableau analytics skills
  • Risk-based qualification methodologies
  • Global process standardization experience
  • Training and coaching capabilities
  • ISPE guidance knowledge

Key Requirements

  • 8-13 years of relevant work experience
  • Bachelor's or Master's degree required
  • Experience in GMP pharmaceutical environment
  • Knowledge of ASTM E2500 or ISPE guidance

Work Rights

Not specified

Tailored Resume

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