Sr Validation Engineer

Amgen Technology Private Limited

Hyderabad

1-9 Years

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Posted 19 days ago
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Job Description

Key Deliverables:

Define and execute validation strategies for GxP-regulated IT systems
Create and manage validation documentation using Veeva VM Testing Vault
Execute test cases, track defects, and ensure compliance with regulatory standards
Generate reports and dashboards on validation progress and defect metrics

Role Responsibilities:

Collaborate with system architects, QA, and business teams to align validation plans
Maintain audit-ready documentation and manage workflows in validation tools
Support end-users and conduct training on validation systems and best practices
Ensure adherence to FDA 21 CFR Part 11, GxP, and global regulatory frameworks

More Info

Job Type:

Permanent Job

Industry:

Pharmaceutical

Role:

Pharmaceutical Research Scientist, Regulatory Affairs Manager, R & D Manager, Documentation /Medical Writing

Function:

Pharmaceutical/Biotechnology

Employment Type:

Full time

Open to candidates from:

Indian

About Company

Amgen Technology Private Limited

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 innovative 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. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average, and we are also part of the Nasdaq-100 Index, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

Job ID: 119723363

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