Validation Engineer I

In this vital role, you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs, and ensuring the availability and performance of critical systems and applications. This position involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions, as well as automating operations, monitoring system health, and responding to incidents to minimize downtime.

Roles & Responsibilities

• Develop and maintain Validation Plans, including scope, responsibilities, deliverables, and timelines.
• Perform risk-based assessments to determine the level of validation required.
• Assist in defining User Requirements and Functional Requirements.
• Draft and review various validation artifacts.
• Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations.
• Coordinate and / or execute validation protocols.
• Support change management processes for validated systems.
• Ensure continuous validation throughout the system lifecycle (including periodic reviews).
• Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time.
• Stay updated with the latest trends and technologies, and related fields.
• Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently.

Basic Qualifications

Preferred Qualifications

Skills Required

Business Analysis, Saas, Incident Management, Mulesoft