7+ years in Computer System Validation (CSV) and SDLC
Experience in FDA and globally regulated environments
Strong understanding of GxP standards
Knowledge of risk-based validation approaches
Responsibilities
Validate Windchill and PLM systems in regulated environments
Write, review, and execute validation documentation
Review system test scripts and user acceptance test (UAT) scripts
Apply QA methodologies to validation processes
Execute test scripts and support defect resolution
Use tools like JIRA, qTest, and ServiceNow for validation tasks
Provide validation guidance and escalate issues as needed
Collaborate with onsite and remote teams on multiple projects simultaneously
Benefits
Hybrid work environment allowing for flexibility
Opportunity to work on multiple high-impact projects
Exposure to FDA and globally regulated standards
Collaborative team atmosphere
Development of skills in advanced validation techniques
Full 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 procedures.
Execute test scripts, review defects, and support defect resolution activities.
Use tools such as JIRA, qTest, ServiceNow, 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.
Experience:
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.
