IT CSV Analyst (R&D)

Job Description

Description:

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:

Full-time