CSV Specialist – AI-enabled systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the planning, execution, and documentation of validation activities for AI-driven applications and systems.

• Help develop and sustain AI validation compliance procedures, templates, and validation deliverables.

• Ensure that AI systems adhere to GxP requirements, regulatory standards, and industry best practices.

• Prepare, review, and maintain documentation that is ready for audits, including validation documents, test evidence, traceability matrices, and compliance records.

• Carry out validation activities in accordance with approved Standard Operating Procedures (SOPs) and established validation frameworks.

• Conduct risk-based testing, quality reviews, and validation assessments to identify and reduce compliance risks.

• Participate in continuous improvement initiatives aimed at enhancing AI validation processes, testing methodologies, and quality practices.

• Collaborate closely with quality, validation, business, and technology teams.

⛳️ Requirements

• Over 5 years of experience in Computer System Validation (CSV), Quality Assurance, or regulated system validation environments.

• Solid understanding of GxP regulations, FDA 21 CFR Part 11, GAMP 5, and other relevant compliance frameworks.

• Experience in supporting validation lifecycle activities, including requirements review, risk assessment, testing, defect management, and documentation.

• Familiarity with AI/ML systems, software validation principles, and regulatory considerations for AI-enabled solutions.

• Demonstrated ability to create, maintain, and review validation documentation, compliance records, and audit evidence.

• Strong analytical, communication, and stakeholder management skills, with the capability to work effectively in cross-functional teams.

🏝️ Benefits

• Paid time off based on employee grade: Vacation: 12-25 days, depending on grade.

• Company paid holidays.

• Personal Days.

• Sick Leave.

• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada).

• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada).

• Life and disability insurance.

• Employee assistance programs.

• Other benefits as provided by local policy and eligibility.

• Additional compensation such as variable incentives, bonuses, or commissions may be available depending on the position and applicable laws.

• Reasonable accommodations during the recruitment process.