CSV Engineer

Overview

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, with the ability to support multiple projects in a hybrid work environment.

• 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 procedures.
• Execute test scripts, review defects, and support defect resolution activities.
• Use tools such as JIRA, qTest, Service Now, XRAY, and perform change record reviews.
• Provide validation guidance, perform timely document reviews, and escalate issues to TQ management as needed.
• Work collaboratively with onsite and remote teams while supporting multiple changes and projects simultaneously.
• Demonstrate strong verbal and written communication skills.
• Work independently, as a team player, or lead validation activities with minimal supervision.

• 3+ years of experience validating Windchill and Product Lifecycle Management (PLM) systems.
• 7+ years of experience in Computer System Validation (CSV) and System Development Life Cycle (SDLC).
• Experience working in FDA and/or globally regulated environments.
• Strong understanding of GxP standards and risk-based validation approaches.