Validation Engineer

Key Responsibilities

• Supervise execution of EO sterilization Performance Qualification (PQ) activities
• Cookordination half-cycle, nominal/full-cycle, and maximum-cycle sterilization runs
• Prepare and manage PCDs (Process Challenge Devices) and Biological Indicators (BIs) for shipment and cycle insertion
• Support preparation and arrangement of dunnage for EO sterilization processes
• Oversee movement of product loads through refrigerated storage, tempering, sterilization, and aeration processes
• Collaborate with Validation, Quality, and Operations teams to support project timelines and execution

Required Qualifications

• Experience in validation within medical device, pharmaceutical, or regulated manufacturing environments
• Hands-on knowledge of EO sterilization validation and PQ execution activities
• Strong understanding of GMP documentation practices and ALCOA+ principles
• Ability to coordinate cross-functional activities and manage execution timelines
• Strong communication and organizational skills