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Job Description
(JD) Mandatory skill : Computer System Validation (CSV) + (MES is mandatory)

Location:
India

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 accurately
• Review 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
• 7+ years of experience in Computer System Validation (CSV) within the Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries.
• Solid understanding of Quality and Validation principles, including risk-based validation approaches.
• Familiarity with:
• Change Control Processes
• Deviation Management
• Risk Assessments (FMEA/GAMP-based)
• Experience with other MES or automation systems. Interested candidate please drop mail to "[email protected]"

📌 CSV - Emerson syncade (Hyderabad)
🏢 HCLTech
📍 Hyderabad