CAREER CATEGORY

Quality

JOB DESCRIPTION

Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest
diseases, and make people’s lives easier, fuller and longer. We discover,
develop, manufacture and deliver creative medicines to help millions of
patients. Amgen helped establish the biotechnology industry more than 40 years
ago and remains on the cutting-edge of innovation, using technology and human
genetic data to push beyond what’s known today.

ABOUT THE ROLE

Senior Validation Engineer

In this role, you will serve patients through collaboration with Amgen's global
Quality, Manufacturing, Process Development, Analytical Sciences, and Supply
Chain organizations, while providing quality oversight of Contract Manufacturing
Organizations (CMOs) supporting Amgen's global supply network.

The primary focus of this position is providing Quality oversight and technical
leadership for analytical method lifecycle activities at external manufacturing
partners, including analytical method validation, method transfer,



verification,
and ongoing performance monitoring. The role will be responsible for reviewing
and approving analytical validation and transfer protocols and reports,
assessing scientific rationale and statistical approaches, evaluating data
integrity, and conducting source data verification to ensure compliance with
regulatory requirements and Amgen expectations.

In addition, the role will provide oversight and guidance for cleaning and
process validation programs supporting synthetic API and peptide manufacturing
operations, including: evaluation of cleaning strategies, acceptance criteria,
sampling approaches, analytical methods, validation strategies and corresponding
protocols, reports, and periodic review activities.

A successful candidate will possess strong technical expertise in analytical
method validation and transfer, a thorough understanding of GMP and data
integrity requirements, and direct e

📌 Senior Validation Engineer (Hyderabad)
🏢 AMGEN
📍 Hyderabad