System Validation Engineer
: Job Details :

Position - System Validation EngineerLocation - Dallas, TX (Onsite )Job typeContract Job ResponsibilitiesRole Description: CSV, Validation, Testing, Reports, Test, data validation, GAMP, CFRCompetencies: EIS : Medical Device & RegulationsExperience (Years): 4-6Essential Skills: 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.Desirable Skills: Role ? Computer System Validation Engineer 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: oValidation (Strategy) Plans, User Requirement Specification so Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs o Qualification Documents and Test Specifications (IQ, OQ, PQ) o Traceability Matrices, Risk Analysiso 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.Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.