IT CSV Analyst (R&D)

Job Description

Job DescriptionDescription:About Tryton TC

Tryton TC is a specialized IT staffing firm that partners with top-tier talent and innovative companies to deliver expert consulting solutions. We pride ourselves on creating long-term, successful relationships with both our clients and our consultants. When you work with Tryton, you're supported by a dedicated team that values responsiveness, transparency, and your professional growth.

Position 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. This individual will support the implementation, configuration, and validation of electronic systems in alignment with corporate policies, procedures, and compliance standards.

Key Responsibilities

• 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.
  

Required Skills & Experience

• 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 (Quality, RIM, CTMS & Safety)
    
  • EDC, Shiny apps, Tracelink, Oracle Fusion, Pinnacle SAS, GLAMS/AMS, Box (for version control)
    
• 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.
  

Requirements: