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Job Title: CSV Quality Support Lead
Primary Skill: Solution Validation
Job Description:
Looking for a CSV Quality Support Lead with experience in Computer System Validation (CSV) and solution validation to support system compliance and quality initiatives.
Key Responsibilities:
Requirements:
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Today
Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati
Full-time
Raritan, New Jersey
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Today
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.
Full-time
