Software Validation Engineer

(3 month Contract / Hourly - In person initially but eventually Hybrid)

Job Description

We are seeking a Software Validation Engineer with a strong focus on Microsoft Power Platform experience.

This role is primarily documentation-focused and involves validation planning rather than traditional software QA. You will be responsible for developing and executing validation plans, ensuring our PowerApps solutions and related systems adhere to regulatory standards and meet business needs.

Key Responsibilities

• Validation Planning: Develop and manage comprehensive validation plans for Microsoft Power Platform applications, including PowerApps and related systems.
• Requirements Analysis: Analyze user requirements and system specifications to create validation documentation that aligns with regulatory and business requirements.
• Documentation Creation: Prepare detailed validation documents, including validation plans, protocols, and reports. Ensure all documentation is thorough, accurate, and compliant with industry standards.
• Test Strategy Design: Collaborate with stakeholders to define test strategies and validate system functionality, performance, and compliance through documented test cases and scenarios.
• Execution Oversight: Oversee execution of validation activities, ensuring test results are accurately documented and issues are addressed promptly.
• Compliance Assurance: Ensure validation processes and documentation comply with relevant regulations and industry standards (e.g., FDA, GxP, 21 CFR Part 11).
• Continuous Improvement: Identify and implement improvements in validation processes and documentation practices.
• Collaboration: Work closely with developers, project managers, and cross-functional teams to align validation efforts with project goals and deliverables.

Qualifications

• Bachelor’s degree in Computer Science, Engineering, or related field (relevant certifications are a plus).
• Extensive experience with the Microsoft Power Platform, including PowerApps and Power Automate.
• Proven expertise in validation planning, documentation, and regulatory compliance.
• Strong understanding of validation principles and industry standards.
• Exceptional documentation skills with high attention to accuracy and detail.
• Experience with 21 CFR Part 11 compliance is required.
• Strong analytical and organizational abilities; ability to work independently and collaboratively.
• Excellent communication skills, including experience presenting technical documentation to stakeholders.
• Familiarity with project management tools like Asana, Smartsheet, or Jira is beneficial.