Validation Engineer

Job Summary

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