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Computer System Validation Engineer (CSV) - Automation

Company: PSC Biotech
Location: Irvine
Posted on: August 6, 2022

Job Description:

PSC Biotech is one of the world's largest consulting firms in the pharmaceutical and biotechnology industry. Currently, we are looking for a Computer System Validation Engineer (CSV) Automation/Controls in Irvine, CA.Responsibilities The ideal Candidate will have 4+ years of experience in CSV, automation, controls in the Manufacturing/Lab Equipment Qualification Responsible for authoring, editing, and executing validation protocols (IQ/OQ) or test scripts. Collaboration with validation documents; design and execution: Validation Plan, Requirements, Roles & Responsibilities, Design & Configuration Specs, Test Plan & scripts, Protocols, SOP plan, Impact-assessment, Specific Site specifications, CSQ audit, Deployment, Training Plan, etc. Experience in a GxP environment is a MUST Prefer knowledge of FDA regulations, such as 21 CFR Part 11, GAMP Requirements Bachelors Degree in science, engineering, or similar field Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Ability to work as a team player in a consulting environment. Proficiency with MS Office tools Documentation management and excellent documentation writing skills. No C2C / No Third Party Resume

Keywords: PSC Biotech, Irvine , Computer System Validation Engineer (CSV) - Automation, IT / Software / Systems , Irvine, California

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