CSV - Emerson syncade

HCL Technologies Limited; Hyderabad; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

HCL Technologies Limited seeks a CSV/MES Validation Specialist in India to lead validation activities across regulatory environments. You will review URS/FS/DS, author validation docs, and support IQ/ST/UAT testing with meticulous documentation and evidence.

You will ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles, while coordinating with QA, IT, and manufacturing to close defects and manage changes.

Qualifications

• Strong experience in CSV within regulated pharma or life sciences.
• 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, ALCOA+ and GAMP 5.
• Manage validation-related deviations, investigations, CAPAs, and change controls.

Responsibilities

• Review URS, FS, DS and business process requirements.
• Author and review SLC documentation in regulatory standards.
• Execute and support IQ, ST, and UAT testing; document results.
• Review test evidence and ensure compliance with approved protocols.
• Support RTM updates and defect management.
• Execute SIT, UAT, Regression, and Validation Testing.
• Verify MES functionality against approved requirements.
• Document test results, screenshots, logs, and evidence.
• Identify, document, and track defects through closure.
• Support Change Control for validated systems.

Skills

Computer System Validation

MES

Tools

ALM tools

Veeva Vault Validation

ServiceNow

Job description

JD:

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.
• Strong understanding of Quality and Validation principles, including risk-based validation approaches.
• Familiarity with:
• Change Control Processes
• Deviation Management
• Experience with other MES or automation systems.