Computer System Validation Engineer

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.

Below are the details for the position-