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 experience

📌 Senior Validation Engineer (Hyderabad)
🏢 AMGEN
📍 Hyderabad