A company is looking for a Validation Engineer to assist with the development and execution of validation protocols for various processes.
Key Responsibilities
Generate and execute life cycle documentation for cleaning, shipping, facilities, utilities, systems, equipment, and processes
Support validation activities for Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents
Write, review, and revise various qualification and verification related documents, including SOPs and validation master plans
Qualifications and Requirements
Bachelor's degree in a related life science field
4-7 years of experience within the biotech, pharmaceutical, or medical device industry
Knowledge and experience with FDA cGMP, FMEA, and Risk Analysis
Validation expertise in Equipment, CSV, Method, and Process
Protocol generation experience for automated production systems
Validation Engineer • Grand Prairie, Texas, United States