Software Validation Specialist
Validation InstituteSan Diego, California, United States
Posted November 5, 2025
80000 - 105000 USD year
Full Time
About the Company
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.
Job Description
VTI Life Sciences is seeking a Software Validation Specialist to ensure compliance with industry standards and regulatory requirements for computerized systems in regulated environments.
Requirements
- Develops test plans, test cases, and test scripts on multiple projects simultaneously.
- Scheduling and execution of qualification activities
- Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications
- Software Design Specification drafting and review
- Create, track, and complete regulated documentation for SW V&V process such as change orders, test plans, reports, and relevant attachments
- Documentation generation and updates (SOPs, PFMEA, Forms, etc.)
- Meeting attendance and project coordination
- Basic SQL Knowledge for (SELECTS, JOINS, and execution queries)
- Identify defects and track them from discovery to resolution
- Conduct manual and automated testing of software
- Work with developers to perform root-cause analysis and preliminary problem diagnosis
- Provide all services in accordance with FDA cGxP guidelines and regulations
Benefits
- Competitive compensation
- Excellent benefits
- Matching 401K