Manager, C&Q Document Preparation (Facilities and Utilities)
Core
Lead the preparation and delivery of commissioning and qualification (C&Q) documentation to support GMP manufacturing, packaging, and facility systems across Amgen's operations.
Role type
Manager, C&Q Document Preparation (Facilities and Utilities)
Builds
Inspection-ready documentation enabling successful commissioning, qualification, and operational readiness of Engineering systems and capital projects.
Domain
Pharmaceutical/Biotechnology, GMP Manufacturing, Facilities & Utilities
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP commissioning and qualification practices, leading blended teams (employees and contingent), risk-based qualification methodologies, GMP documentation and data integrity, cross-functional collaboration, project management, standardized template usage
Preferred skills
Commissioning & Qualification Center of Excellence (CoE) model experience, global Engineering capital projects support, continuous improvement initiatives
Technologies
GMP documentation templates, risk assessment tools, traceability matrices
Responsibilities
Lead team responsible for C&Q documentation preparation and delivery, manage work across blended team ensuring planning and execution, oversee development of qualification protocols and reports, execute C&Q documentation using CoE standards, partner with Engineering and Validation teams, monitor documentation progress and resolve issues, maintain inspection-ready documentation, support regulatory inspections, implement standardized CQ practices, provide leadership and coaching to team members, contribute to continuous improvement initiatives
Seniority
Manager, hands-on IC with team leadership
