Role Senior Software Engineer / Lead Requrement Computer System Validation (CSV) Consultant Experience 3 - 7 years Location Hyderabad / Bangalore / Chennai / Pune Work Mode Hybrid (2 / 3 days WFO) Shift Timing General (11 AM to 8 PM) Key Responsibilites - Execute Computer System Validation (CSV) activities for GxP applications, laboratory systems, manufacturing systems, and enterprise platforms.

- Develop and review validation documentation including: Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications, Design Specifications, Test Scripts (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.

- Ensure compliance with regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q7/Q10) and company SOPs.

- Collaborate with cross-functional teams (QA, IT, Manufacturing, R&D;, and Business Units) to ensure timely validation delivery.

- Perform risk-based assessments to prioritize validation testing.

- Provide audit support for regulatory inspections and internal quality audits.

- Train project teams on CSV processes, documentation standards, and compliance requirements.

- Participate in data integrity assessments and remediation projects.

- Support continuous improvement of CSV procedures, templates, and best practices.

Required Skills - Bachelor s or Master s degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field.





- 3-8+ years of experience in Computer System Validation within GxP-regulated industries (pharma, biotech, medical devices).

- Robust knowledge of GAMP 5 guidelines, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.

- Experience validating Laboratory systems (e.g., LIMS, CDS, ELN), Manufacturing systems (e.g., MES, SCADA, PLCs), ERP (SAP), or Cloud-based systems.

- Hands-on experience with risk-based validation approaches.

- Excellent documentation, analytical, and communication skills.

- 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 Good to Have Skills - Experience with cloud/SaaS validation (AWS, Azure, Veeva, etc.).

- Experience with Testing Tools like Jeera, qTest and ALM

- Knowledge of Agile / SDLC methodologies and their application in CSV.

- Prior involvement in regulatory inspections and client audits.

- Familiarity with 21 CFR Part 820 (Medical Devices) and ISO standards (ISO 13485, ISO 14971).

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 CSV-GXP Professional with AI ML knowledge (Chennai)
🏢 Newt Global
📍 Chennai