Deviation Management Specialist - I (Assistant) - Katalyst Healthcares & Life Sciences

• 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.

Requirements:

• B.S. degree in Engineering or Sciences.

• Minimum one (1) year post-bachelor's degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with <1 year experience).

• Demonstrated ability to drive results to hit assigned due dates.

• Strong communication, collaboration skills and ability to drive accountability.

• Strong problem-solving skillset.

• Vaccine manufacturing.

• Sterile processing.

• Technical writing (e.g. investigations, technical protocols/reports).

• Investigative tools (e.g. 5-whys, fishbone).

• Experience authoring investigations for atypical events in a manufacturing environment.