Csv Engineer

Cirruslabs; Hyderabad, Chennai, Bengaluru; Hybrid; INR 1,800,000 - 2,400,000; Full time

Job summary

CirrusLabs, LLC seeks a validation lead to own GxP validation strategies for regulated systems, covering requirements, traceability, testing, deviations, and audit readiness. You will apply GAMP 5 and CSA to diverse platforms, including SaaS and cloud environments, ensuring data integrity and risk-based approaches.

You will coordinate validation activities across applications, support IQ/OQ, training content, and eLearning platforms, while addressing AI/ML validation considerations and

Qualifications

• Experience with 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.
• 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.

Responsibilities

• Own the validation lifecycle for GxP-regulated systems, covering requirements, specifications, traceability, testing, deviations, change control, CAPA, and audit readiness.
• Apply GxP expectations, GAMP 5, and CSA principles across traditional, agile, and cloud platforms.
• Determine when supplier documentation and testing evidence may be leveraged based on risk and vendor assessments.
• Support Infrastructure Qualification, CSV, CSA, system and functional risk assessment, IT quality, compliance, and governance activities in regulated environments.
• Support agile and waterfall SDLC activities.
• Assess data integrity controls: audit trails, user access, ALCOA+, data lineage, interfaces, and connected systems.
• Support validation of AI/ML-enabled systems considering intended use, data quality, explainability, human oversight, drift monitoring, revalidation triggers.
• Apply pharmacovigilance process knowledge to validation lifecycle activities.
• Coordinate validation across applications, drive stakeholder follow-ups, maintain schedules and deliverables.
• Support IQ/OQ execution, user story development, test planning, training development, and content authoring.
• Provide project/operational support for eLearning platforms, including implementation, integration, maintenance, and sustainability challenges.
• Track actions, manage deadlines, elevate risks or issues promptly.

Skills

GxP regulatory systems

GAMP 5

CSA and data integrity

Risk-based validation

Agile/Hybrid SDLC

Stakeholder coordination

Audit readiness

Cloud/SaaS infrastructure

Tools

JIRA

QTest

ServiceNow

ValGenesis

Job description

Own the validation approach, risk assessment, scope, and testing strategy using GAMP 5 and Computer Software Assurance principles, focusing effort on patient safety, product quality, and data integrity.

Lead validation lifecycle activities for GxP-regulated systems, including requirements, specifications, traceability, testing, deviations, change control, CAPA support, and audit readiness.

Apply GxP expectations, GAMP 5, and CSA principles across traditional, agile, SaaS, cloud-hosted, and modern digital platforms.

Determine when supplier documentation and testing evidence may be leveraged based on risk, intended use, vendor assessment, release impact, and quality arrangements.

Support Infrastructure Qualification, Computer System Validation (CSV), Computer Software Assurance (CSA), system and functional risk assessment, IT quality, compliance, and governance activities in regulated Life Sciences environments.

Support agile and waterfall software development lifecycle activities.

Assess data integrity controls, including audit trails, user access, ALCOA+ principles, data lineage, interfaces, manual processes, and connected systems.

Support validation of AI/ML-enabled systems by considering intended use, data quality, explainability, human oversight, drift monitoring, and revalidation triggers.

Apply knowledge of pharmacovigilance processes, system workflows, regulatory expectations, and supporting documentation to validation lifecycle activities.

Coordinate validation activities across applications and systems, drive stakeholder follow-ups, and maintain schedules, dependencies, and deliverables.

Support IQ/OQ execution, user story development, test planning, training development, and content authoring.

Provide project and operational support for eLearning platforms, including understanding their implementation, integration, maintenance, and sustainability challenges.

Track assigned actions, manage deadlines, and elevate risks or issues promptly

Required Qualifications

• 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 withComputer System Validation (CSV)and/orComputer Software Assurance (CSA)in agile delivery environments.
• Experience applying arisk-based validation approachto Agile releases, features, user stories, and product increments
• Experience integrating quality, compliance, and validation activities intoAgile and hybrid SDLC frameworks
• Experience inIT 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.