CSV Specialist – AI-enabled systems

Job not on LinkedIn

🔥 8 minutes ago

🇺🇸 United States – Remote

💵 $82.1k - $193.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🤖 Artificial Intelligence

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 2%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Capgemini

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1967

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Capgemini is a global leader in partnering with businesses to transform and manage their operations by harnessing the power of technology. With expertise across a wide array of industries such as aerospace, automotive, banking, and healthcare, Capgemini provides a constantly evolving portfolio of services to meet the ever-changing needs of their clients. Their offerings include cloud, cybersecurity, data and artificial intelligence, and enterprise management, among others. Capgemini also emphasizes innovation and sustainability, helping companies achieve digital transformation while promoting environmental and social responsibility. Additionally, Capgemini provides career opportunities across various levels and professions, encouraging innovation and diversity in its workforce.

📋 Description

• Support the planning, execution, and documentation of validation activities for AI-enabled applications and systems • Assist in developing and maintaining AI validation compliance procedures, templates, and validation deliverables • Ensure AI systems comply with GxP requirements, regulatory expectations, and industry best practices • Prepare, review, and maintain audit-ready validation documentation, test evidence, traceability matrices, and compliance records • Execute validation activities according to approved Standard Operating Procedures (SOPs) and established validation frameworks • Perform risk-based testing, quality reviews, and validation assessments to identify and mitigate compliance risks • Contribute to continuous improvement initiatives by enhancing AI validation processes, test methodologies, and quality practices • Work closely with quality, validation, business, and technology teams

🎯 Requirements

• 5+ years of experience in Computer System Validation (CSV), Quality Assurance, or regulated system validation environments • Strong understanding of GxP regulations, FDA 21 CFR Part 11, GAMP 5, and other applicable compliance frameworks • Experience supporting validation lifecycle activities including requirements review, risk assessment, testing, defect management, and documentation • Knowledge of AI/ML systems, software validation principles, and regulatory considerations for AI-enabled solutions • Proven ability to create, maintain, and review validation documentation, compliance records, and audit evidence • Strong analytical, communication, and stakeholder management skills with the ability 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