IT CSV Analyst (R&D) - Remote

Overview

We are seeking a highly skilled IT CSV Analyst (R&D) to provide computer systems validation (CSV) support for R&D systems within a regulated environment.

In Short

• Deliver CSV support for implementation and validation of electronic systems, particularly in R&D functions.
• Lead validation efforts across project lifecycles including risk assessments, validation plans, test scripts, IQ/OQ/PQ protocols, trace matrices, and summary reports.
• Manage change controls and associated tasks while effectively overseeing projects to completion.
• Review and approve life cycle documentation and support ongoing quality-related activities.
• Collaborate with cross-functional teams including business stakeholders, Quality, and IT to ensure validation deliverables meet compliance standards.
• Engage in process improvement initiatives and maintain training compliance.

Requirements

• Strong business analysis (BA) skills with deep understanding of SDLC, testing strategies, and system configuration.
• Proven technical CSV expertise with R&D systems such as Veeva, EDC, Shiny apps, Tracelink, Oracle Fusion, Pinnacle SAS, GLAMS/AMS, and Box.
• Preferred experience in gene therapy, bioinformatics, and Lab Informatics/LabVantage implementation/validation.
• Experience transitioning from traditional CSV to CSA approaches.
• Familiarity with Veeva connector projects and validation strategies, as well as security profiles and DAC configurations.
• Strong critical thinking, problem-solving, and strategic planning in a regulated environment.

Benefits

• Opportunity to work in a dynamic and innovative environment.
• Support for professional growth and development.
• Collaboration with top-tier talent and innovative companies.