Description At Sterigenics, we are dedicated to ensuring the safety of healthcare products through world class sterilization services. We partner with global manufacturers to protect lives by safeguarding the integrity and sterility of their products. We are now seeking an Associate Validation Engineer to join our team. This is an exciting opportunity for someone looking to grow their career in a regulated, technical environment where precision, quality, and continuous improvement are key. About the Role Reporting to the Quality Assurance Manager, the Associate Validation Engineer will support validation activities across the facility to ensure compliance with ISO, QSR, and customer-specific requirements. You will be responsible for assisting with validation projects, preparing documentation, coordinating validation testing, and supporting continuous improvement in quality and operational performance. You’ll collaborate with internal teams including Operations, Engineering, and Quality, as well as external customers, to ensure validation processes meet regulatory and Sterigenics’ standards. Responsibilities • Plan, organize, and coordinate customer validation activities at the facility. • Assist in the development and execution of validation and test protocols. • Support reviews and approvals of customer and consultant validation documentation. • Ensure all validation activities comply with Sterigenics’ QSRs, ISO standards, and regulatory requirements. • Participate in the setup, processing, and sample handling for validation cycles. • Collect and analyze validation data, ensuring accurate reporting. • Manage the proper handling and shipment of samples for bioburden, BET, and residual testing. • Provide validation support for new or existing equipment (IQ/OQ/PQ activities). • Maintain validation records and ensure documentation is up to date and traceable. • Assist with internal process improvements to enhance validation efficiency and compliance. • Liaise with customers and internal teams to resolve technical or validation-related inquiries. • Investigate and document sterility failures for validation activities. • Program Chamber Cycles in the PLC. • Participate in transfer from validation to routine processing activities. Qualifications • Previous experience in a regulated environment (e.g., medical device, pharmaceutical). • Experience in writing or executing validation protocols is preferred. • Understanding of Quality Management Systems and validation principles (IQ/OQ/PQ). • Strong analytical and problem-solving skills. • Excellent written and verbal communication skills. • Proficiency in Microsoft Office and general computer applications. • A degree in Engineering, Science, or a related discipline (or equivalent experience).