Computer System Validation Engineer
Skills
About the role
This is a Computer System Validation and Computer Software Assurance specialist role at Cirruslabs, hybrid across Hyderabad, Pune and Bengaluru. You'll own validation approach, risk assessment and testing strategy for GxP-regulated systems using GAMP 5 and CSA principles. It suits someone with life sciences validation experience who is comfortable working across Agile and Waterfall delivery models.
What you’ll do
- Own validation approach, risk assessment, scope and testing strategy for GxP-regulated systems
- Lead validation lifecycle activities including requirements, traceability, testing, deviations, change control and CAPA support
- Apply GxP, GAMP 5 and CSA principles across traditional, Agile, SaaS and cloud-hosted platforms
- Determine when supplier documentation and testing evidence can be leveraged based on risk
- Support infrastructure qualification, CSV, CSA and functional risk assessments
- Assess data integrity controls including audit trails, access management and ALCOA+ principles
- Support validation of AI/ML-enabled systems
- Coordinate validation activities across multiple applications and manage schedules and stakeholders
What they’re looking for
- Experience working with GxP-regulated systems and Computer System Validation
- Strong knowledge of GAMP 5, CSA, data integrity and risk-based validation
- Experience preparing validation documentation, RTMs, test scripts and change management records
- Experience with SaaS platforms and cloud-hosted applications
- Hands-on CSV and/or CSA experience in Agile delivery environments
- Experience in IT Quality, IT Compliance and IT Risk Management
- Strong stakeholder management and documentation skills
- Practical knowledge of infrastructure and network components
Nice to have
- Hands-on experience with JIRA, qTest, ServiceNow or ValGenesis
- Experience supporting eLearning platforms or Learning Management Systems
- Experience developing training materials, user guides or eLearning content
- Experience within Life Sciences, Pharmaceutical, Biotechnology or Healthcare environments
- Familiarity with validation requirements for AI/ML-enabled systems
What’s on offer
- Compensation range 10-20 Lacs per annum
- Hybrid working arrangement
Questions about this role
Is this role remote?
No, it's a hybrid role based across Hyderabad, Pune and Bengaluru.
How much does it pay?
10-20 Lacs per annum.
How many years of experience do I need?
3 to 8 years.
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