CAREER CATEGORY

Engineering

JOB DESCRIPTION

About the Role

Amgen is seeking a Senior Associate 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 Senior Associate 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 significant 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 foc

📌 C&q Document Preparation Support Hyderabad
🏢 AMGEN
📍 Hyderabad