Senior Test Lead
India
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Job Description
Senior Test Lead
Chennai, Tamil Nadu

Job Summary

Validation Documentation & Execution

Review and understand User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and business process requirements.Author and review test scripts and other System Life Cycle (SLC) documentation in compliance with regulatory standards.Execute and support IQ, ST, and UAT testing activities and document results accuratelyReview test evidence and ensure compliance with approved protocols.Support requirements traceability by contributing to Requirement Traceability Matrix (RTM) updates.Support defect management and validation remediation activities.
MES Testing & Validation ExecutionExecute System Integration Testing (SIT), User Acceptance Testing (UAT), Regression Testing, and Validation Testing.Execute UAT test protocols and document results accurately.Verify MES functionality against approved requirements and specifications.Document test results, screenshots, log files, and execution evidence.Identify, document, and track defects through closure.Ensure testing activities are completed in accordance with approved procedures and timelines.Support Change Control processes for validated systems.CSV & Regulatory ExpertiseStrong experience in Computer System Validation (CSV) within regulated pharmaceutical, biotechnology, or life sciences environments.Proven ability to independently author complete validation documentation from scratch.Hands-on experience executing validation activities throughout the system lifecycle.Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, Data Integrity principles (ALCOA+), and GAMP 5 requirements.Manage validation-related deviations, investigations, CAPAs, and change controls.Stakeholder CollaborationWork closely with Business SMEs, Validation Leads, Quality Assurance, Manufacturing, and IT teams.Provide timely updates on testing progress, risks, and issues.Application & Tool ExperienceExperience working with Application Lifecycle Management (ALM) tools for requirements, testing, traceability, and defect management.Experience with Veeva Vault Validation for document lifecycle management, validation documentation, approvals, and controlled document processes.Experience using ServiceNow for Change Management, Incident Management, Deviation Tracking, and ITSM processes.MES ExperienceExperience supporting MES validation projects.Knowledge of Emerson Syncade MES is preferred.Experience with manufacturing, batch execution, electronic batch records, and shop-floor integrations is advantageous.Preferred Qualifications5–7 years of experience in Computer System Validation (CSV) within the Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries.Strong understanding of Quality and Validation principles, including risk-based validation approaches.Familiarity with:Change Control ProcessesDeviation ManagementRisk Assessments (FMEA/GAMP-based)Experience with other MES or automation systems.

Key Responsibilities

Validation Documentation & ExecutionReview and understand User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and business process requirements.Author and review test scripts and other System Life Cycle (SLC) documentation in compliance with regulatory standards.Execute and support IQ, ST, and UAT testing activities and document results accuratelyReview test evidence and ensure compliance with approved protocols.Support requirements traceability by contributing to Requirement Traceability Matrix (RTM) updates.Support defect management and validation remediation activities.MES Testing & Validation ExecutionExecute System Integration Testing (SIT), User Acceptance Testing (UAT), Regression Testing, and Validation Testing.Execute UAT test protocols and document results accurately.Verify MES functionality against approved requirements and specifications.Document test results, screenshots, log files, and execution evidence.Identify, document, and track defects through closure.Ensure testing activities are completed in accordance with approved procedures and timelines.Support Change Control processes for validated systems.CSV & Regulatory ExpertiseStrong experience in Computer System Validation (CSV) within regulated pharmaceutical, biotechnology, or life sciences environments.Proven ability to independently author complete validation documentation from scratch.Hands-on experience executing validation activities throughout the system lifecycle.Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, Data Integrity principles (ALCOA+), and GAMP 5 requirements.Manage validation-related deviations, investigations, CAPAs, and change controls.Stakeholder CollaborationWork closely with Business SMEs, Validation Leads, Quality Assurance, Manufacturing, and IT teams.Provide timely updates on testing progress, risks, and issues.Application & Tool ExperienceExperience working with Application Lifecycle Management (ALM) tools for requirements, testing, traceability, and defect management.Experience with Veeva Vault Validation for document lifecycle management, validation documentation, approvals, and controlled document processes.Experience using ServiceNow for Change Management, Incident Management, Deviation Tracking, and ITSM processes.MES ExperienceExperience supporting MES validation projects.Knowledge of Emerson Syncade MES is preferred.Experience with manufacturing, batch execution, electronic batch records, and shop-floor integrations is advantageous.Preferred Qualifications5–7 years of experience in Computer System Validation (CSV) within the Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries.Strong understanding of Quality and Validation principles, including risk-based validation approaches.Familiarity with:Change Control ProcessesDeviation ManagementRisk Assessments (FMEA/GAMP-based)Experience with other MES or automation systems.

Skill Requirements

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Other Requirements

Validation Documentation & ExecutionReview and understand User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and business process requirements.Author and review test scripts and other System Life Cycle (SLC) documentation in compliance with regulatory standards.Execute and support IQ, ST, and UAT testing activities and document results accuratelyReview test evidence and ensure compliance with approved protocols.Support requirements traceability by contributing to Requirement Traceability Matrix (RTM) updates.Support defect management and validation remediation activities.MES Testing & Validation ExecutionExecute System Integration Testing (SIT), User Acceptance Testing (UAT), Regression Testing, and Validation Testing.Execute UAT test protocols and document results accurately.Verify MES functionality against approved requirements and specifications.Document test results, screenshots, log files, and execution evidence.Identify, document, and track defects through closure.Ensure testing activities are completed in accordance with approved procedures and timelines.Support Change Control processes for validated systems.CSV & Regulatory ExpertiseStrong experience in Computer System Validation (CSV) within regulated pharmaceutical, biotechnology, or life sciences environments.Proven ability to independently author complete validation documentation from scratch.Hands-on experience executing validation activities throughout the system lifecycle.Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, Data Integrity principles (ALCOA+), and GAMP 5 requirements.Manage validation-related deviations, investigations, CAPAs, and change controls.Stakeholder CollaborationWork closely with Business SMEs, Validation Leads, Quality Assurance, Manufacturing, and IT teams.Provide timely updates on testing progress, risks, and issues.Application & Tool ExperienceExperience working with Application Lifecycle Management (ALM) tools for requirements, testing, traceability, and defect management.Experience with Veeva Vault Validation for document lifecycle management, validation documentation, approvals, and controlled document processes.Experience using ServiceNow for Change Management, Incident Management, Deviation Tracking, and ITSM processes.MES ExperienceExperience supporting MES validation projects.Knowledge of Emerson Syncade MES is preferred.Experience with manufacturing, batch execution, electronic batch records, and shop-floor integrations is advantageous.Preferred Qualifications5–7 years of experience in Computer System Validation (CSV) within the Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries.Strong understanding of Quality and Validation principles, including risk-based validation approaches.Familiarity with:Change Control ProcessesDeviation ManagementRisk Assessments (FMEA/GAMP-based)Experience with other MES or automation systems.
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Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 227,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending March 2026 totaled $14.7 billion.