Principal Software Engineer

Role: Principal Software Engineer leading automation solutions within biopharma operations, R&D, manufacturing, and finance. Objectives: design and develop rapid Proof-of-Concept (POC) automation tools to streamline workflows, improve quality, and enhance productivity, supporting GxP and FDA-regulated environments. Responsibilities: collaborate with process SMEs to translate process needs into validated digital solutions; support computerized systems validation, documentation, and lifecycle management; work within Agile frameworks, supporting CI/CD pipelines with GitLab and Jenkins; ensure compliance with 21 CFR Part 11 and other regulatory standards. Qualifications: Bachelor’s in Mechanical, Industrial Engineering, or related field; 5+ years' experience in automation testing using UFT, Selenium, Automation Anywhere; proficiency in Java, C#, VBScript, VBA, and supporting GxP regulated systems; experience supporting CSV activities and managing projects through full lifecycle. Preferred: experience with incident, problem, and change management; strong documentation skills; familiarity with FDA regulations. High-value: automation in regulated environments, cross-disciplinary project leadership, supporting digital transformation in biopharma operations, with telecommuting flexibility.