Senior CSV Analyst

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