Validation Engineer III

The Validation Engineer III ensures regulatory compliance by overseeing the validation of systems, equipment, and processes while managing the full lifecycle of Computer System Validation and cross-functional projects. The role plays a critical part in driving technical transfers, optimizing validation strategies, and leading continuous improvement initiatives to enhance operational efficiency.

Requirements

• Bachelor of Science degree in a scientific or engineering discipline
• 10 years Validation experience in the pharmaceutical or biotechnology industries
• Advanced knowledge in current good manufacturing practices, CQV, sterilization validation, Good Automated Manufacturing Practice, 21 Code of Federal Regulations Part 11, and experience with Computer System and Cleaning Validation
• Strong project management, problem-solving, and analytical skills with attention to detail and proficiency in Microsoft Office and Quality Management Systems