CSV Lead

📋 Description

• Lead CSV and compliance for capital/strategic projects
• Validate lifecycle for computerized systems in GMP env
• Provide guidance on CSV/CSA, SDLC, risk-based validation
• Define risk mitigation for compliance risks
• Maintain oversight through system lifecycle
• Collaborate across Quality, Engineering, IT/OT, and project teams

🎯 Requirements

• 5+ years of professional CSV experience
• Hands-on CSV in GMP/manufacturing environments
• Strong knowledge: SDLC, IQ/OQ/PQ, CAPA, deviation, data integrity
• Proven ability to develop/approve validation docs
• Experience with FDA/EMA regulatory expectations
• English fluency; ability to work remotely

🎁 Benefits

• Freelance / contract engagement
• Full-time ~40 hrs/week
• Start date: Sep 2026
• Opportunity to contribute to major pharmaceutical projects
• Exposure to GxP-regulated systems and cross-functional teams