Job Opportunities

System Validation Engineer

Job Title: System Validation Engineer
Experience: 5+ years
Job Type: Contractual / Temporary
Work Location: Remote
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 Skills:
*ERP/LIMS/QMS/MES validation, electronic records/signatures, audit and inspection support.

Interested candidates can mail their resume to careers@appsteamtechnologies.com along with the subject line "System Validation Engineer Application".