Validation Engineer
Amgen · Hyderabad, India
QualityFull-timeCompany career page
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Role summary
Validation Engineer role at Amgen focused on ensuring pharmaceutical systems compliance through computerized system validations and GAMP implementation. The position involves developing validation documentation, test protocols, and regulatory specifications to meet GxP requirements across manufacturing operations.
What they're looking for
- Master's degree with 8-12 years validation/regulatory experience, or Bachelor's with 10-14 years
- Minimum 3-5 years pharmaceutical industry experience in computer systems validation and GAMP
- Knowledge of FDA, EMEA, CFDA, and other regulatory frameworks
- Expertise in GAMP 5, 21 CFR Part 11, and CFR Parts 210/211 compliance
- Proficiency with Veeva platform modules and ALM testing software
- Strong understanding of SDLC methodologies and software testing best practices
What you'll be doing
- Advise clients on compliance requirements using risk-based approaches for computerized systems
- Develop validation documentation, SOPs, and test protocols aligned with GxP requirements
- Create and execute IQ/OQ scripts and validation specifications with oversight of test execution
- Collaborate with business functions and subject matter experts to develop requirements specifications
- Support deviation analysis and work with clients to develop comprehensive validation plans
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.