Validation Engineer

Job Summary

To support critical manufacturing and quality processes in the Pharmaceutical and Biomedical sectors, the full-time Validation Engineer will author and execute validation protocols, manage compliance documentation, and conduct risk assessments.

Key Responsibilities:

• Author, execute, and review validation protocols (IQ, OQ, PQ) for manufacturing equipment and laboratory instruments
• Support and execute process and cleaning validation activities in aseptic and biologics manufacturing environments
• Ensure compliance with FDA, cGMP, and internal Quality Management System (QMS) requirements, managing deviations and change controls

Required Qualifications:

• Bachelor's degree in Biomedical Engineering, Chemical Engineering, Biotechnology, Pharmaceuticals, or a closely related scientific field
• 1-10 years of hands-on validation experience within the Pharmaceutical, Biotech, or Medical Device industries
• Deep understanding of cGMPs, FDA 21 CFR Part 210/211, FDA 21 CFR Part 11, and relevant ISO standards