ABOUT THE ROLERole Description:
- In this vital role, you will lead the preparation and delivery of commissioning and qualification (CQ) documentation that supports Engineering project execution and GMP manufacturing, packaging, and facility systems across Amgens operations.
- The Manager, CQ Document Preparation will lead a blended team of employees and contingent workers responsible for preparing compliant, inspection-ready documentation that enables successful commissioning, qualification, and operational readiness of Engineering systems and capital projects.
- This role works closely with Engineering, Automation, Process Development, Validation, Quality, Manufacturing, Facilities, and Project teams to ensure documentation is delivered with high quality and aligned with project timelines.
- This position plays a key role in executing standardized CQ documentation practices within the Center of Excellence (CoE) and supporting consistent documentation quality across Engineering projects and sites.
- This position may support one or more areas including Drug Substance, Drug Product,



Finished Drug Product Packaging, or Facilities Utilities.

Roles Responsibilities:
- Lead a team responsible for preparation and delivery of CQ documentation supporting commissioning and qualification activities across Engineering projects and systems.
- Manage work across a blended team of employees and contingent resources, ensuring effective planning, prioritization, and execution of deliverables.
- Oversee development of qualification protocols, reports, risk assessments, traceability matrices, and related qualification documentation.
- Execute CQ documentation preparation using established CoE standards, templates, and processes to ensure consistency, compliance, and efficiency.
- Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities.
- Monitor documentation progress, identi

📌 Manager, C&Q Document Preparation (Hyderabad)
🏢 Amgen
📍 Hyderabad