Computer System Validation Engineer

Cloudxtreme; Hyderabad, Pune District, Chennai District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Cloudxtreme is seeking a qualified validation specialist to work on GxP-regulated systems, including CSV and CSA within agile delivery. You will integrate quality, compliance, and validation activities across SaaS and cloud infrastructures while coordinating with stakeholders and ensuring audit readiness.

The role emphasizes risk-based validation for Agile releases, with a focus on infrastructure components and cloud service models. Strong documentation and collaboration skills are essential.

Qualifications

• Experience in GxP-regulated systems and computer system validation.
• Knowledge of GAMP 5, CSA, data integrity, and risk-based validation.
• Experience with validation documentation, traceability, testing, deviations, change management, and audit readiness.
• Experience with SaaS, cloud-hosted applications, or qualified cloud infrastructure.
• Strong experience with Computer System Validation (CSV) and/or Computer Software Assurance (CSA) in agile delivery environments.
• Experience applying a risk-based validation approach to Agile releases, features, user stories, and product increments
• Experience integrating quality, compliance, and validation activities into Agile and hybrid SDLC frameworks
• Experience in IT quality, IT compliance, IT risk management, and quality oversight
• Strong stakeholder coordination, documentation, and delivery-management skills
• Practical knowledge of infrastructure and network components, including servers, virtual machines, storage, databases, load balancers etc.
• Understanding of cloud service models, including IaaS, PaaS, SaaS, hybrid cloud, and managed services
• Hands-on experience with JIRA, Qtest, ServiceNow and ValGenesis.
• Experience with eLearning or learning-management platforms.
• Experience developing training materials and authoring eLearning content.

Skills

GxP compliance

GAMP/CSA

CSV/CSA experience

Agile/Hybrid SDLC

Documentation & traceability

Cloud infrastructure knowledge

IT quality & risk

Stakeholder coordination

Tools

JIRA

Qtest

ServiceNow

ValGenesis

Job description

Experience with GxP-regulated systems and computer system validation.

• Working knowledge of GAMP 5, CSA, data integrity, and risk-based validation.
• Experience with validation documentation, traceability, testing, deviations, change management, and audit readiness.
• Experience working with SaaS, cloud-hosted applications, or qualified cloud infrastructure.
• Strong experience with Computer System Validation (CSV) and/or Computer Software Assurance (CSA) in agile delivery environments.
• Experience applying a risk-based validation approach to Agile releases, features, user stories, and product increments
• Experience integrating quality, compliance, and validation activities into Agile and hybrid SDLC frameworks
• Experience in IT quality, IT compliance, IT risk management, and quality oversight
• Strong stakeholder coordination, documentation, and delivery-management skills..
• Practical knowledge of infrastructure and network components, including servers, virtual machines, storage, databases, load balancers etc.
• Understanding of cloud service models, including IaaS, PaaS, SaaS, hybrid cloud, and managed services

Preferred Qualifications

• Hands-on experience with JIRA, Qtest, ServiceNow and ValGenesis.
• Experience with eLearning or learning-management platforms.
• Experience developing training materials and authoring eLearning content.