CSV Lead

Accountabilities:

• Lead CSV and compliance activities for capital and strategic projects.
• Plan, execute, review, and approve validation lifecycle documentation.
• Provide expert guidance on CSV/CSA, SDLC, risk-based validation, IQ/OQ/PQ, change control, CAPA, and data integrity.

Requirements:

• 5+ years of hands-on CSV experience in GMP-regulated pharmaceutical environments.
• Strong knowledge of validation lifecycle management, GxP, SDLC, and risk-based validation.
• Experience with DeltaV, Rockwell or Siemens PLCs, process historians, or lab automation.

Benefits:

• Freelance/contract engagement with full-time allocation (~40 hrs/week).
• Opportunity to work on complex GxP-regulated systems and international projects.
• Collaborate with multidisciplinary teams across Quality, Engineering, Automation, IT/OT, and lab functions.