CSV Engineer

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

Summary Mandatory - Validation experience with ERP applications / SAP / MES Experience in validating ERP/SAP/ MES Manufacturing applicationsRoles & responsibility Preferred tools knowledge and experience: JIRA, SAP Solution Manager, XRAY and Change Record review Should be experienced in Test scripts, executions and defect reviews. Strong verbal and written communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote te

Job Summary: CSV Engineer to support commissioning and validation activities for a newly built Cell & Gene Therapy R&D and manufacturing facility in Pittsburgh, PA. The role focuses on reviewing validation deliverables, ensuring compliance with regulatory standards (21 CFR Part 11, GAMP 5), and coordinating with commissioning teams handling facilities, utilities, MES, EMS, CMMS, and related systems. The consultant will work within environments using Kneat, Microsoft Office, and automation platfo

Roles & Responsibilities: - Build and maintain ETL pipelines, metadata, mappings, and automated data quality/validation rules. Configure elluminate study modules (Mapper, Data Central, CTOA, Sample Management, Protocol Deviations) and translate requirements into specifications. Contribute in testing/validation (IQ/OQ/PQ, UAT) efforts, manage audit trails, and resolve issues with vendors and study teams. Develop dashboards/analytics across elluminate modules and monitor system performance, inte