Engineer II, Manufacturing

About This RoleThe Engineer II Manufacturing designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for assigned process equipment and area assets. Develops validation protocols, executes validation testing and drafts final reports. Provides project engineering as required for new processing equipment installations and modifications to existing equipment.What You'll DoSupport Manufacturing operations by troubleshooting issues and identifying equipment system improvements. Review standards, drawings and specifications as necessary.Identify and lead equipment related projects, including technology transfers, capital projects, and modifications. Provide input & guidance to Tech Transfer and project / area efforts, provide technical evaluations of validation requirements for core change controls & associated action plans.Author sections of Validation-related reports & project plans, provide SME assessments on Trackwise-generated workflows (deviations, global change controls) for equipment / automation-related changes.Coordinate Equipment/Cleaning Validation Protocols (development, training, execution, management, tracking) for manufacturing areas. Specifically design & develop validation protocols, provide expertise to associated equipment & automation design / modifications, support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required.Management of process equipment, onboarding, revisions to lifecyle documents, continuous improvements, and decommissioning.Who You AreYou are accountable for achieving milestones in equipment projects, involving frequent internal and external communication. As a representative of the Manufacturing Engineering organization, your role carries the weight of potential delays and extra resource allocation if errors occur in your decisions or recommendations. Your commitment lies in delivering accurate and timely results, ensuring efficient processes to prevent setbacks.