Validation Engineer

Job Summary

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