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 Execution Execute 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 Expertise Strong 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 Collaboration Work closely with Business SMEs, Validation Leads, Quality Assurance, Manufacturing, and IT teams.Provide timely updates on testing progress, risks, and issues. Application & Tool Experience Experience 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 Experience Experience 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 Qualifications 5–7 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 & 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 Execution Execute 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 Expertise Strong 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 Collaboration Work closely with Business SMEs, Validation Leads, Quality Assurance, Manufacturing, and IT teams.Provide timely updates on testing progress, risks, and issues. Application & Tool Experience Experience 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 Experience Experience 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 Qualifications 5–7 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.
Other Requirements
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 Execution Execute 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 Expertise Strong 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 Collaboration Work closely with Business SMEs, Validation Leads, Quality Assurance, Manufacturing, and IT teams.Provide timely updates on testing progress, risks, and issues. Application & Tool Experience Experience 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 Experience Experience 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 Qualifications 5–7 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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