Validation Engineer

Job Summary

Supporting the development and management of validation activities, the full-time Validation Engineer will ensure compliance with quality standards and regulatory requirements by generating and executing validation lifecycle documentation for equipment and processes in Waltham, Massachusetts.

Key Responsibilities

• Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for GMP regulated assets
• Support validation activities for tech transfer projects, including authoring and reviewing validation documents
• Write and revise qualification and verification documents, including SOPs and validation plans

Required Qualifications

• 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
• Demonstrated experience writing IQ, OQ, PQ, and CSV reports