Engineering, Specialist, Technical Operations Deviation Management

Role: Incoming Materials Deviation Management Specialist supporting West Point manufacturing operations, focusing on deviation investigations related to supplier, incoming materials, and environmental monitoring. Responsibilities: authoring incident and investigation reports, managing CAPAs, supporting deviation reduction initiatives, leading or participating in continuous improvement projects, performing root cause analysis, authoring and reviewing GMP documentation, providing on-floor project support, and supporting regulatory inspections. Requirements: B.S. in Engineering, Sciences, or related discipline; minimum two years post-bachelor’s experience in a regulated environment with expertise in deviation management, change control, or biopharma equipment validation. Preferred: biologics, vaccine, or sterile manufacturing experience, project management, and root cause analysis skills. High-Value: biologics/vaccine manufacturing, GMP environment, deviation and change management, regulatory support, and engineering support for process and equipment validation. WorkSetup: hybrid onsite in West Point, PA; no travel required.