Manager Computer System Validation

Company Name: Bristol Myers Squibb

Job Overview

Drives computer system validation activities for Manufacturing Execution Systems (MES) at the Summit, NJ Cell Therapy manufacturing site.

Responsibilities:

• Leading end-to-end validation
• Authoring documentation
• Coordinating MES/recipe validation

Compliance:

Ensures compliance with 21 CFR Part 11 and GAMP 5, validating electronic batch records and system interfaces.

Requirements:

• Strong IT/Computer Science foundation
• 5+ years of pharma/biotech experience
• Excellent project management and collaboration skills