Computer System Validation Engineer Lead Job Overview
The Computer System Validation Engineer Lead will spearhead and oversee the CSV qualification of GxP computerised systems involved in the Global Capex Project.
The ideal candidate will possess in-depth knowledge and expertise in GXP system operation (Automation/IT) and Validation, including operational & data lifecycle requirements as they relate to GXP computerised Equipment/Systems.
1. Guiding and overseeing the overall CSV approach and validation methodology outlined in the CSV program, ensuring it is conducted in accordance with relevant site procedures and applicable regulations.
2. Providing expert guidance to resolve complex issues that arise, ensuring solutions and decision-making processes are managed in a collaborative and transparent manner.
3. Effectively managing stakeholder expectations through regular reporting meetings.
The position requires relevant academic qualifications (Degree) and/or extensive industry experience of 10+ years in biotech/pharmaceutical industries qualifying GXP systems.