Key Responsibilities:

Looking for immediate joiners.

Location - Hyderabad Only

Experience - 7+ years

- Use risk based approach and critical thinking in implementing validation approach.
- Provide CSV support to the Quality and Compliance function working closely with Business and IT stakeholders, App and Infra support teams.
- Ability to independently lead validation activities, provide compliance guidance, and serve as the CSV Subject Matter Expert (SME) during projects, audits, and inspections
- Responsible for supporting the ongoing validation activities across Application landscape.
- Provides on-going validation management support to plan, prioritize and deliver system enhancements, general releases, hotfixes, as well as product periodic revalidation.
- Closely collaborate with Application Managed services Team and Business/IT stakeholders to ensure requirements/specifications are defined in a clear, testable, and compliant format
- Effectively work with cross-functional teams (Product Management, Testing, Technical Operations) to ensure the validated state of the system/application is maintained
- Ensure requirements are adequately tested following a risk-based approach
- Identify and log issues found during validation execution. Work closely with Product and Testing teams to identify and prioritize issues early on and track validation incidents to closure.
- Ensure clear traceability against all testing performed
- Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices.
- Independent pre and post-execution review of validation test scripts
- Prepare validation summary reports for executed protocols.
- Updates of the system inventory to ensure that is maintained at all times. e.g., addition of systems, retirement of systems, periodic review dates, etc.
- Management/input of Change Control, CAPA, Deviations.
- Ability to act as responder in audits.




- Experience with technologies such as Infra (IaaS, PaaS, & SaaS), Microsoft 365, SharePoint Online, Azure, AWS, VMware, SQL Server, Oracle, ServiceNow, Salesforce, Veeva, E1, TrackWise, Controlant, TraceLink, or similar enterprise platforms is highly desirable.
- Experience applying GAMP 5, FDA 21 CFR Part 11, EU Annex 11, ALCOA+, and Data Integrity principles to ensure computerized systems remain compliant and inspection-ready.
- Experience supporting new system implementations, upgrades, enhancements, patches, hotfixes, and system retirement activities while maintaining a validated state
- Strong knowledge of Computer System Lifecycle Management (CSLM), Software Development Life Cycle (SDLC), and change management processes in regulated environments.
- Hands-on experience validating cloud and SaaS applications, including assessment of supplier validation packages, release management processes, and cloud compliance controls.
- Experience working in Agile, Waterfall, or hybrid project delivery models, ensuring validation activities are integrated into project execution.
- Proven stakeholder management and communication skills with the ability to influence cross-functional teams and drive compliance-focused decisions.

Experience/Skillset Requirements:

- Degree (Bachelors or Masters) in Computer/Electrical/Electronics Engineering or other relevant Field.
- Hands-on experience with the validation of commercial, R&D; and ERP and Corporate applications used for regulated activities in the pharmaceutical industry
- Knowledge of Agile software development, and software testing methodologies.
- Excellent written and oral communication skills, positive decision-making skills, and time management skills.
- Experience with cloud-based applications and/or infrastructure (IaaS, PaaS, & SaaS) compliance.
- Ability to lead validation workstreams with minimal supervision.

📌 Csv Engineer (Hyderabad)
🏢 Genpact
📍 Hyderabad