Validation Engineer

A company is looking for a Validation Engineer to support validation activities in a CDMO environment.

Key Responsibilities

Generate and execute validation lifecycle documentation for GMP regulated assets

Support validation activities for tech transfer projects, including authoring and executing validation documents

Write, review, and revise qualification and verification documents and prepare summary reports for validation activities

Qualifications and Requirements

Bachelor's degree in a life science, engineering, or related technical field

4-7 years of experience in the biotech, pharmaceutical, or medical device industry

Strong knowledge of FDA cGMP requirements and risk-based validation principles

Hands-on validation experience in equipment and computerized systems

Experience generating protocols for automated production systems and writing IQ, OQ, PQ, and CSV reports