Computer System Validation Engineer

Job Description

**Location: Remote**
**Duration: 6 months**
**Visa: OPT, H1B, H4 EAD, GC EAD, GC, USC**
**Computer System Validation Engineer**
* Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
* Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
* Compliance Analysis, Validation Planning, Risk Assessments
* Test planning and strategy
* creation and execution of test protocols, scripts and reports.
* Validation Summary Reports, traceability analysis.
* Defect Logging and Tracking till closure.

**Responsibilities**
* Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
* Author and update documentation to support ongoing CSV compliance.
* Prepare or review all levels of validation documents including:
* Validation (Strategy) Plans, User Requirement Specifications
* Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs
* Qualification Documents and Test Specifications (IQ, OQ, PQ)
* Traceability Matrices, Risk Analysis
* Validation Reports, Change Controls/ Events / Deviations etc
* Assess the impact of changes proposed to computerized systems and the level of change required.
* Provide validation strategy to the introduction of computerized systems.
* Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc) and management on all related matters on a regular basis.

**Required**: **CSV, Validation, Testing, Reports, Test, data validation, GAMP, CFR**

**You can send your resume to vadkar@tekservcorp.com**