Senior Packaging Engineer

Job Title: Senior Packaging EngineerLocation: North Haven, CT Job Summary:Seeking a Senior Packaging Engineer with 4+ years of medical device packaging and validation experience, supporting terminally sterilized medical devices.Key Responsibilities:Design and develop sterile medical device packaging per ISO 11607, ASTM, and ISTA standards.Execute IQ/OQ/PQ and packaging process validation activities.Support packaging equipment including FFS, bar sealers, and Alloyd systems.Develop and review validation protocols, reports, SOPs, and controlled documentation.Troubleshoot packaging processes/equipment and implement corrective actions.Manage projects, timelines, suppliers, and cross-functional activities.Requirements:Bachelor’s degree in Packaging, Mechanical, Manufacturing Engineering, or related field.4+ years of relevant experience in medical device packaging.Experience with sterile barrier systems and terminally sterilized medical devices.Strong knowledge of ISO 11607, FDA 21 CFR Part 820, GMP, IQ/OQ/PQ, and process validation.Experience with packaging materials and equipment.Project management experience.DOE/Minitab, CSV, change control, and custom equipment validation preferred.