Validation Engineer

Roles & Responsibilities: 10+ years. Experience with CSV, upgrades, enhancements, and operational support procedures. Demonstrated ability to understand, analyze and document complex business processes, translate business needs and functional requirements into technical or process-driven solutions. Experienced and self-directed individual able to work independently and collaboratively in matrixed team environment, lead business users/stakeholders and DTE team members to complete assigned workstream tasks in a timely manner and with expected level of quality. Strong communication, interpersonal and collaborative skills. Solid analytical and problem-solving abilities. Experience in system configurations for a CSV system implementation, including sample management, results analysis, lab workflow, release & stability management, Lab Execution Systems (LES) / Electronic Lab Notebooks (ELN) etc. Document and present complex issues, design options and solutions to a variety of audiences. Participate in the computer system validation (CSV) planning and execution of the solutions, authoring and/or contributing to key system Life cycle (SLC) & CSV deliverables. Partner with managed services team members and peers for platform and database support, as well as technical development for enhancements and projects. Work closely with Compliance, Internal Audit and Quality Assurance groups as needed to ensure compliance with GxP regulations, as well as our DTE system lifecycle and change management.

Created: 2026-04-02