Job Purpose

We are looking for a detail-oriented and experienced CSV Engineer to plan, execute, and document computer system validation activities. You will work closely with Quality Assurance (QA), IT, Operations, and external vendors to ensure our software, laboratory, and manufacturing systems comply with global regulatory requirements.

Key Responsibilities

- Validation Strategy &
- Planning:

Develop and execute risk-based validation strategies, Validation Plans (VPs), User Requirement Specifications (URS), and Functional/Design Specifications (FS/DS). [3, 4]
- Protocol Execution: Write, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and test scripts. [4]
- Traceability &
- Compliance: Maintain Requirements Traceability Matrices (RTM) and ensure full compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. [3, 4, 5]
- Data Integrity &
- Assessments: Conduct Data Integrity Assessments, audit trail reviews, and ALCOA+ principle verifications across electronic systems. [3, 6]
- Defect &
- Change Control Management: Manage deviations, change controls, root-cause analysis, and CAPA (Corrective and Preventive Actions)



during and post-validation. [3]
- Audits &
- Inspections: Act as a technical subject matter expert (SME) during internal audits, client audits, and regulatory inspections (e.g., FDA, EMA).
- Cloud &
- SaaS/AI Systems: Support the validation of cloud-based SaaS applications, enterprise platforms (e.g., eQMS, ERP, LIMS), or AI-enabled systems as applicable.

Required Qualifications &
- Skills

- Education: Bachelor’s degree in Computer Science, Life Sciences, Pharmaceutical Sciences, or Engineering. [4]
- Experience: [2–5 years] of hands-on experience in Computer System Validation within a GxP/pharmaceutical/biotech setting. [4]
- Regulatory Knowledge: Deep understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and cGMP standards. [3, 4]
- Technical Skills:
- Hands-on experience writing URS, FRS, IQ/OQ/PQ, and Validation Summary Reports.
- Familiarity with tracking and quality tools (e.g., Jira, Confluence, Veeva, Kneat, TrackWise, or HP ALM). [3, 4, 6, 7]
- Soft Skills: Strong technical writing, analytical problem-solving, and cross-functional communication skills. [3]

📌 Computer System Validation (CSV) Engineer (Hyderabad)
🏢 Teclusion
📍 Hyderabad