Computer Systems Validation Consultant

Job Summary

Independently managing Computer System Validation projects, the full-time Computer Systems Validation Consultant will provide consulting services focused on authoring validation documents, executing verification tests, and performing technical writing in a hybrid work environment.

Key responsibilities

• Author Validation Plans, Test Plans, User and Functional Requirements Specifications, and qualification protocols (IQ/OQ/PQ)
• Execute qualification protocols, collect testing evidence, document deviations, and author compliance and validation reports
• Participate in CSV Practice meetings and contribute to company programs while ensuring clear communication of activities to the Project Manager

Required qualifications

• B.S./B.A. in Engineering, Science, Information Technology, or a related field, or equivalent experience
• Minimum 3 years of experience in Computer System Validation and related Pharmaceutical or Healthcare Industries
• Experience validating at least two categories of computer systems such as clinical data management, laboratory systems, or quality management systems
• Basic knowledge of FDA GxPs, regulatory guidelines, and industry best practices like GAMP5
• Proficiency in Microsoft Word and Excel, with the ability to quickly learn new software applications