Greetings from HCL Tech

Location - Bangalore / Chennai / Pune/ Noida / Hyderabad

JD

(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