Remote Computer Systems SPC Validation Engineer in Irvine

Location: California

Compensation: To Be Discussed

Staff Reviewed: Wed, Sep 30, 2020

This job expires in 9 days

Job Category: Information Technology

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

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