What are the responsibilities and job description for the Manufacturing Engineer position at Select Source International?
Main Responsibilities
Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
Generate and execute validation protocols (IQ. OQ PQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
Conduct process equipment installation/operational/performance qualification studies to test their functionality.
Support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.
Other duties as assigned.
Required Skills
The bulk of work is qualification and validation.
Transfer of catheter manufacturing into PR.
Writing and testing protocols.
Process knowledge required – ability to apply in PPQ setting.
Ability to do time studies, value, non-value added.
Software – Timer Pro, SAP, Office Timeline Pro, Power BI, Windchill (Nice to have).
Going from document design history records, moving to digital – previous technical transfer experience preferred, not required.
Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
Generate and execute validation protocols (IQ. OQ PQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
Conduct process equipment installation/operational/performance qualification studies to test their functionality.
Support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.
Other duties as assigned.
Required Skills
The bulk of work is qualification and validation.
Transfer of catheter manufacturing into PR.
Writing and testing protocols.
Process knowledge required – ability to apply in PPQ setting.
Ability to do time studies, value, non-value added.
Software – Timer Pro, SAP, Office Timeline Pro, Power BI, Windchill (Nice to have).
Going from document design history records, moving to digital – previous technical transfer experience preferred, not required.
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