Lead I - Software Testing

UST; Chennai District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

UST in Chennai seeks a Validation Engineer with 5–8 years of experience to support validation activities for regulated systems and applications within Life Sciences and Clinical Research.

Responsibilities include creating validation plans, protocols, and documentation; performing risk assessments and impact analyses; and supporting audits and inspections while working with cross-functional teams to ensure compliance and quality standards.

Qualifications

• Experience in CSV/Software Validation or QA.
• Knowledge of Validation Lifecycle, SDLC, STLC, IQ, OQ, PQ, URS, and RTM.
• Familiarity with GxP and regulatory compliance requirements including 21 CFR Part 11 and Annex 11.

Responsibilities

• Execute validation activities for applications, systems, and business processes.
• Create and maintain validation plans, protocols, reports, and traceability matrices.
• Perform risk assessments and impact analyses for system changes.
• Support system implementations, enhancements, and upgrades.
• Collaborate with cross-functional teams to ensure compliance and quality standards.
• Support audit and inspection readiness activities.

Skills

GxP

CSV

EU Annex 11

FDA 21 CFR Part 11

Validation Engineering

Compliance Management

Risk Management

Requirements Gathering

SDLC

Jira

Process Documentation

Tools

Jira

ALM

Azure DevOps

Job description

Role Description

Hiring: Validation Engineer We are looking for a Validation Engineer with 5-8 years of experience to join our team and support validation activities for regulated systems and applications within the Life Sciences and Clinical Research domain.

Key Requirements

• Experience in Computer System Validation (CSV), Software Validation, or Quality Assurance.
• Strong understanding of Validation Lifecycle, SDLC, STLC, IQ, OQ, PQ, URS, and RTM.
• Knowledge of GxP, 21 CFR Part 11, Annex 11, and regulatory compliance requirements.
• Experience in preparing and executing validation protocols, test scripts, and validation documentation.
• Familiarity with tools such as Jira, ALM, or Azure DevOps.
• Strong analytical, troubleshooting, and documentation skills.

Responsibilities

• Execute validation activities for applications, systems, and business processes.
• Create and maintain validation plans, protocols, reports, and traceability matrices.
• Perform risk assessments and impact analyses for system changes.
• Support system implementations, enhancements, and upgrades.
• Collaborate with cross-functional teams to ensure compliance and quality standards.
• Support audit and inspection readiness activities.

Preferred

• Experience in Life Sciences, Clinical Research, Pharmaceutical, or Healthcare domains.
• Exposure to SaaS platforms and cloud-based systems.
• Understanding of Agile methodologies and regulatory compliance frameworks.

Skills

• GxP
• CSV
• EU Annex 11
• FDA 21 CFR Part 11
• Validation Engineering
• Compliance Management
• Risk Management
• Requirements Gathering
• SDLC
• Jira
• Process Documentation