CSV Lead

📋 Description

• Lead CSV and compliance activities for capital and strategic projects involving computerized
• Plan, execute, review, and approve validation lifecycle activities per GxP and regulatory
• Provide expert guidance on CSV/CSA, SDLC, risk-based validation, system qualification, IQ/OQ/PQ
• Conduct and review system risk assessments and define validation strategies with mitigations for
• 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 hands-on Computer System Validation in GMP-regulated
• Proven track record supporting validation and compliance for computerized manufacturing systems.
• Strong knowledge of validation lifecycle management, CSV/CSA, GxP/GMP, SDLC, IQ/OQ/PQ, change
• Ability to develop, review, and approve validation documentation and other compliance deliverables.
• Understanding of FDA, EMA, and international regulatory expectations for computerized systems in
• Experience with manufacturing automation or IT/OT environments; exposure to DeltaV

🎁 Benefits

• Freelance / contract engagement.
• Full-time allocation of approximately 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.
• Opportunity to work across multidisciplinary teams across Quality, Engineering, Automation, IT/OT