Senior CSV/CSA Specialist

Job Summary

Leading validation efforts for complex GxP computerized system projects, the full-time Senior CSV/CSA Specialist will oversee validation planning, execution, and documentation while collaborating with IT and Quality Assurance in a remote capacity.

Key responsibilities

• Lead validation and assurance planning for new systems, upgrades, and changes, coordinating activities across project teams and stakeholders
• Author and review validation lifecycle deliverables to ensure compliance with regulatory and quality standards
• Provide expert guidance on validation documentation and support audits, inspections, and remediation plans related to computerized systems

Required qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field, or equivalent experience
• 7+ years of experience in CSV/CSA, GxP IT quality, validation, or regulated system lifecycle
• Strong knowledge of CSV, CSA, GAMP 5, and regulatory requirements such as 21 CFR Part 11 and EU Annex 11
• Experience leading validation strategy for complex systems, including laboratory and cloud/SaaS environments
• Ability to mentor others and facilitate cross-functional communication regarding validation practices