Lead the preparation and delivery of commissioning and qualification documentation that supports Engineering project execution and GMP manufacturing, packaging, and facility systems across Amgen’s operations
Job Summary
Lead the preparation and delivery of commissioning and qualification documentation that supports Engineering project execution and GMP manufacturing, packaging, and facility systems across Amgen’s operations.
Manage a blended team of employees and contingent workers responsible for preparing compliant, inspection-ready documentation that enables successful commissioning, qualification, and operational readiness.
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities.
Matching Summary
Lead the preparation and delivery of commissioning and qualification documentation that supports Engineering project execution and GMP manufacturing, packaging, and facility systems across Amgen’s operations.
Skills & Requirements
Must-have
C&Q documentation preparation
GMP manufacturing systems
Engineering project execution
Blended team leadership
Risk-based qualification methodologies
Nice-to-have
Inspection-ready documentation
Continuous improvement initiatives
Coaching and development
Key Requirements
8-13 Years of work experience
Bachelors or Masters degree
Experience in GMP commissioning, qualification, validation, or technical operations