Career Category
Engineering
Job Description
About the Role
Amgen is seeking a Manager specializing in Commissioning & Qualification (C&Q;) to join the Engineering C&Q; Center of Excellence (CoE). In this role, you will support the preparation, coordination, and delivery of commissioning and qualification lifecycle documentation supporting engineering projects and GMP manufacturing systems across Amgen operations.
The Manager will partner closely with Engineering, Validation, Quality, Manufacturing, Facilities, Automation, and Project teams to develop compliant, inspection-ready documentation that supports commissioning, qualification, and operational readiness activities. This role plays an key part in ensuring documentation quality, consistency, and alignment with established C&Q; standards, procedures, and regulatory expectations.
This position may support one or more areas including Drug Substance, Drug Product, Finished Drug Product & Packaging, or Facilities & Utilities.

Roles & Responsibilities




Prepare and revise commissioning and qualification lifecycle documentation supporting Engineering projects and systems
Author qualification protocols, reports, risk assessments, traceability matrices, test scripts, and related C&Q; documentation
Support document development activities using approved templates, standards, and CoE procedures
Coordinate technical review cycles and incorporate comments and revisions into final documents
Ensure documentation is accurate, complete, compliant, and inspection-ready
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to gather technical information
Track assigned deliverables and support execution against project schedules and milestones
Maintain document organization and version control within applicable quality systems
Support audit and inspection readiness activities as required
Contribute to continuous improvement initiatives focused on documentation quality, con

📌 Manager, C&q Document Preparation Hyderabad
🏢 AMGEN
📍 Hyderabad