Responsibilities:

• Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize, and/or gain efficiencies.
• Manages timelines to ensure key compliance and customer due dates are met; escalates any potential misses and develops remediation plans when possible.
• Assures consistent application of standardized work, engineering, and process tools.
• Provides technical support to manufacturing shop floor for problems and issues.
• Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.