Job Description
Job Summary:
The CSV Engineer will be responsible for validating Windchill and Product Lifecycle Management (PLM) systems in an FDA and/or globally regulated environment.
This role requires strong knowledge of GxP standards, risk-based validation, and Computer System Validation (CSV) practices, along with the ability to support multiple projects in a hybrid work environment.
Roles & Responsibilities: Validate Windchill and Product Lifecycle Management (PLM) systems in regulated environments.
Write, review, and execute validation documentation including requirements, compliance/validation plans, test protocols, test summary reports, and validation reports.
Review system test scripts, user acceptance test (UAT) scripts, traceability matrices, and design specifications.
Apply QA methodologies while designing, reviewing, and approving test plans, system test scripts, UAT test scripts, and test pro...