GxP CSV Engineer with strong AI Validation Exp

Cygnus Professionals Inc.; India; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Cygnus Professionals Inc. seeks an experienced AI Validation Tester to ensure accuracy and regulatory compliance for AI-enabled, GxP-regulated applications.

The role focuses on risk-based validation, CSV activities, and robust testing across AI/GenAI outputs in regulated environments. The ideal candidate has 5+ years of functional software testing experience, including RPA testing, Jira/qTest proficiency, and exposure to AI governance and lifecycle validation.

Qualifications

• 5+ years of functional software testing experience.
• RPA knowledge and testing experience – mandatory.
• Strong knowledge of GxP and CSV.
• Knowledge of risk-based validation methodologies and modern CSV approaches.
• Experience in pharmaceutical/life sciences manufacturing.
• Hands‑on experience with Jira and qTest or similar test management tools.
• Experience with Generative AI / AI productivity solutions.
• Exposure to Generative AI, LLMs, prompt engineering, and AI response evaluation.
• Experience validating AI solutions for accuracy, consistency, relevance, hallucination, bias, and inappropriate responses.
• Knowledge of AI governance, model risk management, or responsible AI principles.
• Support AI risk assessments, model verification, bias testing, explainability testing, performance monitoring, and AI lifecycle governance.
• Experience working with electronic records, electronic signatures, audit trails, and data integrity controls.
• Experience supporting internal and external regulatory audits/inspections.

Responsibilities

• Perform functional, integration, regression, and validation testing for GxP-regulated applications and AI-enabled solutions.
• Develop and execute test cases, test scenarios, test scripts, and validation protocols.
• Support CSV/GxP validation activities, including requirements traceability, test evidence, defect management, and validation documentation.
• Test and validate RPA/automated business processes, including workflows, exceptions, and integrations.
• Evaluate AI/GenAI outputs for accuracy, consistency, relevance, and expected behavior.
• Identify, document, and track defects using Jira and qTest.
• Work closely with QA, IT, business, validation, and AI teams in an Agile/Scrum environment.
• Ensure compliance with GxP, data integrity, audit trail, and applicable regulatory requirements.

Skills

Functional testing

Regression testing

Test case development

Validation testing

RPA testing

GxP knowledge

CSV testing

AI/GenAI validation

Jira

qTest

Risk-based validation

Agile/Scrum

Stakeholder collaboration

Tools

Jira

qTest

Microsoft Copilot

Job description

We are looking for an experienced AI Validation Tester with a minimum of 5+ years of relevant experience. The ideal candidate should have strong expertise in GxP, Computer System Validation (CSV), regulatory standards, and the validation of AI/ML solutions.

The candidate should have a strong understanding of risk-based validation approaches, regulatory compliance, and testing methodologies for AI solutions in regulated environments.

Key Responsibilities

• Perform functional, integration, regression, and validation testing for GxP-regulated applications and AI-enabled solutions.
• Develop and execute test cases, test scenarios, test scripts, and validation protocols.
• Support CSV/GxP validation activities, including requirements traceability, test evidence, defect management, and validation documentation.
• Test and validate RPA/automated business processes, including workflows, exceptions, and integrations.
• Evaluate AI/GenAI outputs for accuracy, consistency, relevance, and expected behavior.
• Identify, document, and track defects using Jira and qTest.
• Work closely with QA, IT, business, validation, and AI teams in an Agile/Scrum environment.
• Ensure compliance with GxP, data integrity, audit trail, and applicable regulatory requirements.

Preferred / Good-to-Have Skills

• 5+ years of functional software testing experience.
• RPA knowledge and testing experience – mandatory.
• Strong knowledge of GxP and CSV.
• Knowledge of risk-based validation methodologies and modern CSV approaches.
• Experience in pharmaceutical/life sciences manufacturing.
• Hands‑on experience with Jira and qTest or similar test management tools.
• Experience with Microsoft Copilot or other enterprise generative AI/AI productivity solutions.
• Exposure to Generative AI, Large Language Models (LLMs), prompt engineering, and AI response evaluation.
• Experience validating AI solutions for accuracy, consistency, relevance, hallucination, bias, and inappropriate responses.
• Knowledge of AI governance, model risk management, or responsible AI principles.
• Support AI risk assessments, model verification, bias testing, explainability testing, performance monitoring, and AI lifecycle governance.
• Experience working with systems involving electronic records, electronic signatures, audit trails, and data integrity controls.
• Experience supporting internal and external regulatory audits/inspections.