Generate qualification/validation documents, SOPs, risk assessments, URS, and plans.
Review validation protocols, studies, and summary reports for GMP systems.
Maintain validated status via periodic review and requalification.
Apply CSV and Data Integrity/ALCOA+ to process and analytical systems.
Oversee contractors; support vendor qualification and risk assessments.
Support change control for facility, equipment, and utility validation.

🎯 Requirements

Bachelor's degree in Engineering or a scientific field; 8+ years GMP experience.
Minimum 5 years hands-on qualification/validation experience.
Knowledge of 21 CFR Part 210/211, Device GMPs (820), EU GMPs Annex 1.
Knowledge of SDLC concepts and GAMP5; 21 CFR Part 11.
Excellent technical writing skills and good documentation practice.
Self-motivated, detail-oriented; collaborative in an agile environment.

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