Job Description

Job Title:

System Validation Engineer

Experience: 5+ years

Job Type: Contract

Prefer Immediate joiners

Role Purpose:

Execute computer system validation (CSV) activities to ensure regulated systems are compliant, fit for intended use, and approved for production.

Compliance Scope:

ICH E6 (GCP), FDA 21 CFR Part 11, EU Annex 11, GDPR, HIPAA, ISO 9001, ISO 27001, GAMP 5.

Core Responsibilities:

Author and maintain

Validation Plan

defining scope, deliverables, testing strategy, acceptance criteria, and responsibilities. Review and approve

System Design Documentation

(architecture, infrastructure, database, interfaces, configuration). Develop

Testing Plan

and author/pre-approve

Validation Protocols (IQ/OQ/PQ)

with defined steps and expected results. Execute or oversee validation testing on production or equivalent systems; document and approve results. Review

Code Review Reports

and verify

Unit Test Results

for development compliance. Manage

Validation Incident Reports

, including impact assessment, corrective actions, regression testing, and closure. Maintain

Traceability Matrices

(URS ? FRS ? Design ? Tests) ensuring complete coverage. Prepare

Testing Summary Report

and

Validation Summary Report

authorizing production release. Support

Deployment Plan

execution and perform

Installation Qualification (IQ)

; ensure IQ reusability.

Required Qualifications:

Bachelor's degree in Engineering, Computer Science, IT, or equivalent. Proven experience in CSV within regulated (GxP) environments. Strong knowledge of SDLC, risk-based validation, and validation documentation.

Key Skills:

Technical documentation, system architecture understanding, compliance focus, cross-functional collaboration.

Preferred:

ERP/LIMS/QMS/MES validation, electronic records/signatures, audit and inspection support.

Job Type: Contractual / Temporary

Work Location: Remote