CSV Lead

📋 Description

• Lead CSV and compliance activities for capital and strategic projects involving computerized
• Plan, execute, review, and approve validation lifecycle activities and documentation per GxP and
• Provide expert guidance on CSV/CSA, SDLC, risk-based validation, system qualification, IQ/OQ/PQ
• Conduct and review system risk assessments, define validation strategies, and ensure mitigation of
• Maintain compliance oversight during system implementation, modification, operation, and retirement.
• Collaborate with Quality, Engineering, Automation, IT/OT, laboratory, business, and project teams

🎯 Requirements

• 5+ years of professional experience with strong hands-on Computer System Validation in GMP
• Experience supporting validation/compliance activities for computerized manufacturing systems.
• Strong knowledge of validation lifecycle management, CSV/CSA, GxP/GMP, SDLC, IQ/OQ/PQ, change
• Proven ability to develop, review, and approve validation documentation and other compliance
• Understanding of FDA, EMA, and international regulatory expectations for computerized systems in
• Ability to assess compliance risks and provide practical solutions and guidance to project teams.

🎁 Benefits

• Freelance / contract engagement.
• Full-time allocation of ~40 hours per week.
• Expected start date: September 2026.
• Opportunity to contribute to major pharmaceutical manufacturing and capital projects.
• Exposure to complex GxP-regulated systems and international compliance requirements.
• Work across multidisciplinary teams (Quality, Engineering, Automation, IT/OT, laboratory, project