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Validation Engineering I

Validation Engineering I

Amgen Technology Private Limited

1 - 9 years

1 - 9 Lacs

Hyderabad Telangana India

Posted:1 month ago| Platform: Foundit logo

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Skills Required

Validation Lifecycle CSA Implementation Veeva Validation Management SaaS Systems

Work Mode

On-site

Job Type

Full Time

Job Description

Key Deliverables:

Develop and execute validation plans and protocols for GxP-regulated systems
Ensure system documentation complies with 21 CFR Part 11, Annex 11, and CSA guidance
Support change control, incident handling, and periodic review for validated systems
Collaborate with cross-functional teams to maintain continuous validation throughout the lifecycle

Role Responsibilities:

Perform risk-based assessments and define validation scope and strategy
Coordinate user and functional requirement gathering and document reviews
Maintain validation artifacts using platforms like Veeva, KNEAT, or ALM
Provide post-deployment support and ensure ongoing system compliance

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