IT/Software Validation Engineer(CSV)
Location: Oregon City, CA (Remote also accepted)
Duration: 6+ Months Contract
Job Description:
Lead validation activities for GxP-compliant IT/software systems. Author and review validation plans, test plans, reports, and risk assessments. Ensure compliance with corporate SOPs, coordinate globally with QA, IT, and business teams, and maintain audit readiness. Support system implementation, maintenance, and retirement planning while optimizing validation processes. Provide guidance, training, and consultancy on CSV best practices.
Top Skills:
CSV, GAMP, Validation Plan, Test Plan, Risk Assessment, GxP, SAP, MES, Audit, Compliance, Software Validation, Data Migration, System Review, Process Optimization, Global Projects, IT/Software Validation
Must-Have Skills:
Computerized System Validation (CSV)
GxP/GAMP compliance
Validation planning, execution, and reporting
Risk assessment & mitigation for software systems
Project coordination with Product Owners, Scrum Masters, Architects, and QA teamsExperience with SAP, MES, and G Suite
System implementation, maintenance, and retirement planning
Documentation review and audit readiness