Computer System Validation Engineer

Cirruslabs; Gurugram District; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

CirrusLabs, LLC is seeking a Computer System Validation-GxP professional in Gurugram, Haryana. The role focuses on validation strategy, risk assessment, and ensuring data integrity across traditional, agile, and modern digital platforms, including cloud-based systems.

You will oversee IQ/OQ execution, change control, CAPA support, and audit readiness to maintain validated states, with attention to ALCOA+ principles and regulatory expectations for GxP environments.

Qualifications

• Experience with GAMP 5 / CSA validation frameworks.
• Ability to manage validation deliverables, deviations, change control and CAPA.
• Familiarity with IQ/OQ testing and validation lifecycle.

Responsibilities

• Owns validation approach, risk assessment, scope, and testing strategy.
• Oversees validation of SaaS and cloud-hosted applications, including vendor assessment and supplier evidence.
• Ensures data integrity, audit trails, and ALCOA+ controls across interfaces and systems.
• Handles AI/ML validation needs including data quality, explainability, and revalidation triggers.

Job description

Job Title: Computer System Validation-GxP

Description:

Timings : 11:00 AM - 8:00 PM

Owns validation approach, risk assessment, scope, and testing strategy using GAMP 5 / CSA principles to ensure effort is focused on patient safety, product quality, and data integrity. Manages validation deliverables, deviations, change control, CAPA support, traceability, and audit readiness to maintain the validated state of regulated systems. Applies GxP expectations, GAMP 5 , and CSA guidance across traditional, agile, and modern digital platforms, including knowing when supplier documentation can be leveraged Oversees validation of SaaS and cloud-hosted applications, including vendor assessment, shared-responsibility understanding, release impact review, and use of supplier evidence and quality agreements. Ensures controls around audit trails, access, ALCOA+, data lineage, and integrity risks across interfaces, manual processes, and connected systems. Understands validation needs for AI/ML-enabled systems, including intended use, data quality, explainability, drift monitoring, human oversight, and revalidation triggers. understanding of PV processes, system workflows, regulatory expectations, documentation and support for validation lifecycle activities Cloud platform knowledge, and underlying services/tech stack for qualification, manages qualification deliverables, change control, specifications, traceability to maintain the qualified state Process knowledge of GxP frameworks and coordination across applications/systems undergoing GxP validation activities; Experience with IQ/OQ execution, user story creation, validation, testing, and change management; Ability to drive stakeholder follow-ups and keep deliverables on track; Training development and content authoring; eLearning Platform Support: Hands-on experience with eLearning platforms; Understanding of typical patterns and challenges in building and sustaining these platforms from a project management perspective