Validation Engineer

Job Summary

Seeking dedicated Validation Engineers, the full-time opportunity will involve executing validation protocols, supporting process validation in pharmaceutical manufacturing, and ensuring compliance with FDA and cGMP standards.

Key Responsibilities:

• Author, execute, and review validation protocols (IQ, OQ, PQ) for pharmaceutical 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