Director, Process Validation & Risk Management

Company Name: Vaxcyte

Job Overview

The Director, Process Validation and Risk Management is accountable for commercial process validation and the identification, assessment, and mitigation of operational, technical, and regulatory risks within end-to-end manufacturing processes.

Responsibilities

• Developing validation strategies
• Supporting continuous process validation
• Guiding deviation resolution
• Influencing engineering/facility/systems/method validations

Requirements

• 10+ years of relevant experience in chemical/biochemical engineering or related fields
• Protein synthesis process experience preferred
• Strong knowledge of quality risk management (ICH Q9)
• Excellent communication/problem-solving skills