CSV-GXP Professional with AI ML knowledge

Newt Global; Chennai District; Hybrid; INR 900,000 - 1,300,000; Full time

Job summary

Newt Global is seeking a Senior Software Engineer / Lead to drive CSV validation efforts across GxP systems, including laboratory and manufacturing platforms. The role requires 3–7 years of experience and will involve collaboration with QA, IT, and R&D teams in a hybrid setup across multiple Indian locations.

The candidate should have strong knowledge of GAMP 5, FDA 21 CFR Part 11, and data integrity principles, with hands-on experience in CSV documentation and risk-based validation approaches.

Qualifications

• Bachelor's or Master's degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field.
• 3-8+ years of Computer System Validation within GxP-regulated industries such as pharma, biotech, or medical devices.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
• Experience validating Laboratory systems (LIMS/ELN), Manufacturing systems (MES/SCADA/PLC), ERP (SAP), or Cloud-based systems.
• Hands-on experience with risk-based validation approaches.
• Excellent documentation, analytical, and communication skills.

Responsibilities

• Execute CSV activities for GxP applications, lab systems, manufacturing systems, and enterprise platforms.
• Develop and review validation documentation: Validation Plans, Risk Assessments, URS, FS, DS, IQ/OQ/PQ, Traceability Matrices, Validation Summary Reports.
• Ensure compliance with regulatory requirements and company SOPs.
• Collaborate with 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.
• Participate in data integrity assessments and remediation projects.
• Support continuous improvement of CSV procedures, templates, and best practices.

Skills

CSV Validation

GxP Validation

Regulatory Compliance

Documentation

Cross-functional Collaboration

Risk-based Validation

Education

Bachelor's or Master's in CS/Engineering/Life Sciences/Pharmacy

Tools

Jira

qTest

ALM

Job description

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).
• Strong 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.