CSV Lead

📋 Description

• Lead CSV and compliance activities for capital and strategic projects.
• Plan, execute, review validation lifecycle per GxP and regs.
• Provide expert CSV/CSA guidance across SDLC and risk-based validation.
• Define validation strategies and mitigation for identified risks.
• Maintain oversight through system implementation, modification, operation, retirement.
• Collaborate with Quality, Engineering, Automation, IT/OT, lab, and project teams.

🎯 Requirements

• 5+ years of professional CSV experience in GMP/pharma/manufacturing.
• Experience validating computerized manufacturing systems.
• Strong knowledge of validation lifecycle, CSV/CSA, GxP, SDLC, IQ/OQ/PQ, change control, CAPA
• Proven ability to develop, review, and approve validation docs.
• Understanding of FDA/EMA/regulatory expectations for computerized systems.
• Ability to assess compliance risks and guide project teams.

🎁 Benefits

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