Job Summary
A professional services firm is seeking a Remote Computer Systems SPC Validation Engineer in Irvine.
Core Responsibilities Include:
- Developing Performance Qualification scripts based on configuration
- Developing Installation Qualifications based on Design
- Updating application system User Requirements, Functional, and Design Specifications
Must meet the following requirements for consideration:
- Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices
- University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp
- Minimum 3 to 5 years in pharmaceutical industry, focusing on Validation
- Validation experience with analytics platoforms. Such as, Spotfire, Discoverant, Minitab and/or PowerBI
- Ability to understand existing and new business processes and requirements to ensure proper implementation
- Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice
