Deviation Management Specialist - I - Talent Software Services, Inc.
West Point, PA 19486
About the Job
" 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:
" B.S. degree in Engineering or Sciences.
Required Experience and Skills:
" 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.
Preferred Experience and Skills:
" 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
" 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:
" B.S. degree in Engineering or Sciences.
Required Experience and Skills:
" 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.
Preferred Experience and Skills:
" 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
Source : Talent Software Services, Inc.
