- 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.
Qualifications :
Education Minimum Requirements :
degree in Engineering or Sciences.
Required Experience and Skills :
- Minimum one () year post-bachelor's degree experience in a GMP (good manufacturing practices) manufacturing and / or technical support of GMP manufacturing operations (or degree with < 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.
Preferred Experience and Skills :
- Vaccine manufacturing
- Sterile processing
- Technical writing ( investigations, technical protocols / reports)
- Investigative tools ( -whys, fishbone)
- Experience authoring investigations for atypical events in a manufacturing environment
11 days ago