Computer System Validation Engineer

Cirruslabs; Hyderabad, Pune District, Bengaluru; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Cirruslabs is seeking a Computer System Validation (CSV) / Computer Software Assurance (CSA) Specialist in Hyderabad to lead validation strategy for GxP-regulated systems, focusing on patient safety, product quality, and data integrity.

You will drive validation across Agile and Waterfall lifecycles, manage RTMs, test scripts, deviations, change control, and supplier documentation, while coordinating across applications and stakeholders.

Qualifications

• Experience with GxP-regulated systems and CSV.
• Strong knowledge of GAMP 5, CSA, Data Integrity, and Risk-Based Validation.
• Experience preparing and managing Validation documentation, RTMs, test scripts, deviations, change management, and audit readiness.
• Experience with SaaS platforms, cloud-hosted apps, and qualified cloud infrastructure.
• Hands-on CSV/CSA in Agile delivery environments and risk-based validation for Agile releases.

Responsibilities

• Own validation approach, risk assessment, scope, and testing strategy using GAMP 5 and CSA principles.
• Lead validation lifecycle for GxP-regulated systems including requirements, traceability, testing, deviations, investigations, change control, CAPA, and audits.
• Apply GxP, GAMP 5, and CSA across traditional, Agile, SaaS, cloud-hosted, and digital platforms.
• Determine when supplier documentation and testing evidence can be leveraged based on risk, use, vendor qualification, release impact, and quality agreements.
• Support IQ/OQ, risk assessments, IT quality/compliance, governance activities in regulated Life Sciences environments.
• Support Agile and Waterfall software development lifecycle activities; manage data integrity controls and AI/ML validation considerations.

Skills

GxP-regulated systems

CSV

GAMP 5

CSA

Data Integrity

Risk-Based Validation

SaaS

Cloud-hosted

IT Quality

IT Compliance

IT Risk Management

Quality Oversight

Stakeholder management

Documentation

Delivery management

Agile/Hybrid SDLC

AI/ML validation familiarity

Pharmacovigilance processes

Validation documentation

Tools

JIRA

qTest

ServiceNow

ValGenesis

Job description

Computer System Validation (CSV) / Computer Software Assurance (CSA) Specialist

Key Responsibilities

• Own the validation approach, risk assessment, scope, and testing strategy using GAMP 5 and Computer Software Assurance (CSA) principles, with a focus on patient safety, product quality, and data integrity.
• Lead validation lifecycle activities for GxP-regulated systems, including:
  • Requirements and specifications
  • Traceability
  • Testing and test execution
  • Deviations and investigations
  • Change control
  • CAPA support
  • Audit readiness activities
• 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 can be leveraged based on:
  • Risk assessment
  • Intended use
  • Vendor qualification/assessment
  • Release impact
  • Quality agreements
• Support:
  • Infrastructure Qualification (IQ)
  • Computer System Validation (CSV)
  • Computer Software Assurance (CSA)
  • Functional and system risk assessments
  • IT quality, compliance, and governance activities in regulated Life Sciences environments
• Support both Agile and Waterfall software development lifecycle activities.
• Assess data integrity controls, including:
  • Audit trails
  • User access management
  • ALCOA+ principles
  • Data lineage
  • Interfaces and integrations
  • Manual processes
  • Connected systems
• Support validation of AI/ML-enabled systems by evaluating:
  • Intended use
  • Data quality
  • Explainability
  • Human oversight
  • Drift monitoring
  • Revalidation triggers
• Apply knowledge of pharmacovigilance processes, system workflows, regulatory requirements, and supporting documentation to validation activities.
• Coordinate validation activities across multiple applications and systems while managing schedules, dependencies, deliverables, and stakeholder communications.
• Support:
  • IQ/OQ execution
  • User story development
  • Test planning
  • Training material development
  • Content authoring
• Provide project and operational support for eLearning and Learning Management Systems (LMS), including implementation, integration, maintenance, and sustainability activities.
• Track assigned actions, manage deadlines, and proactively elevate risks and issues.

Required Qualifications

• Experience working with GxP-regulated systems and Computer System Validation (CSV).
• Strong knowledge of:
  • GAMP 5
  • CSA (Computer Software Assurance)
  • Data Integrity
  • Risk-Based Validation
• Experience preparing and managing:
  • Validation documentation
  • Requirements Traceability Matrix (RTM)
  • Test scripts and execution
  • Deviations
  • Change management
  • Audit readiness activities
• Experience working with:
  • SaaS platforms
  • Cloud-hosted applications
  • Qualified cloud infrastructure
• Strong hands-on experience with CSV and/or CSA in Agile delivery environments.
• Experience applying a risk-based validation approach to:
  • Agile releases
  • Features
  • User stories
  • Product increments
• Experience integrating quality, compliance, and validation activities into Agile and Hybrid SDLC frameworks.
• Experience in:
  • IT Quality
  • IT Compliance
  • IT Risk Management
  • Quality Oversight
• Strong stakeholder management, documentation, coordination, and delivery management skills.
• Practical knowledge of infrastructure and network components, including:
  • Servers
  • Virtual Machines (VMs)
  • Storage systems
  • Databases
  • Load balancers
  • Networking fundamentals
• Understanding of cloud service models, including:
  • Infrastructure as a Service (IaaS)
  • Platform as a Service (PaaS)
  • Software as a Service (SaaS)
  • Hybrid Cloud
  • Managed Services

Preferred Qualifications

• Hands-on experience with:
  • JIRA
  • qTest
  • ServiceNow
  • ValGenesis
• Experience supporting eLearning Platforms or Learning Management Systems (LMS).
• Experience developing:
  • Training materials
  • User guides
  • eLearning content
• Experience within Life Sciences, Pharmaceutical, Biotechnology, or Healthcare environments.
• Familiarity with validation and compliance requirements for AI/ML-enabled systems.