Validation Engineering Lead

Role Overview
WuXi Biologics is seeking a highly experienced Validation SME to lead Commissioning, Qualification, and Validation (CQV) activities for our Singapore site. As a Subject Matter Expert (SME), you will manage the entire system lifecycle—from initial requirements analysis to full-scale manufacturing readiness. You will be responsible for ensuring that all equipment, facilities, and utilities for Drug Substance (Upstream/Downstream) and Drug Product (Aseptic Filling/Lyo) meet global regulatory standards and WuXi Biologics' internal quality excellence.
Key Responsibilities
1. Facility Start-up & C&Q Leadership
Develop validation SOPs and C&Q deliverables for project start-up and operation readiness
Plan, manage and coordinate C&Q activities with internal and external resources/stakeholders
Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if required
Attend equipment FAT/training as required
Track the C&Q ...