Senior CSV Analyst

Job Summary

To support a pivotal period in computer system validation, the full-time Senior CSV Analyst will manage the validation lifecycle across GxP systems remotely, ensuring inspection readiness and compliance with regulatory standards.

Key responsibilities:

• Assist with gap assessments and remediation planning for validation packages against regulatory standards
• Lead validation activities for new and existing GxP computerized systems, including the development of validation deliverables
• Support inspection readiness by preparing system summaries and managing document retrieval during inspections

Required qualifications:

• Bachelor's degree in life science, engineering, computer science, or related field, or equivalent experience
• Minimum of 6 years of computer system validation experience in an FDA-regulated environment
• Direct participation in at least one FDA or EMA inspection or formal inspection readiness program
• Hands-on validation experience with cloud or SaaS applications
• Strong technical writing skills with a proven track record of producing inspection-ready documentation