Develop technical knowledge on manufacturing equipment and processes
Support resolution of major equipment breakdowns and quality issues in the suites
Provide SME support to Manufacturing and other departments for the design and operation of process equipment
Conduct troubleshooting and technical analyses on manufacturing equipment and processes including PI data analyses, CIP/SIP circuit review, MOC analyses, flow path analyses, etc.
Projects
Planning and execution of plant projects involving equipment changes and process improvements
Execute commissioning protocols (installation, operation, CIP/SIP, wet testing) with support and guidance from supervisor
Documentation
Review/revise Engineering and Manufacturing related SOPs, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, error prevention activities, etc.
Complete engineering review/approval of batch records
Initiate EDCRs for updates to Engineering documents including engineering drawings