Computer System Validation Engineer

Job Title: Computer System Validation Engineer 
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