Major Responsibilities

• Oversee the computerized system life cycle and ensure compliance with GxP standards and established procedures.
• Develop and maintain Computer System Validation (CSV) plans in alignment with 21 CFR Part 11 requirements.
• Manage deviations, change controls, investigations, and CAPA protocols.
• Author CSV protocols and related documentation.
• Review and approve documents before and after execution.

Job Qualifications / Minimum Requirements

• At least 3 years CSV exp and 1-year exp with Emerson DeltaV hardware/software system