Validation Engineer

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