Duc Pham

Background

About Duc Pham

Responsible for all New Sterilizer Projects and Sterilizer Replacement Projects. •Initiate RCI (Request Capital Investment) for New Sterilizers Projects. •Engineering, Design, and Implement Sterilizer Projects. •Review and Approve design drawings and equipment specifications. •Manage and Execute Sterilizer projects from Start to Finish through FAT/SAT/IOQ/PQ. •Budget planning. •Review and Evaluate contractor’s bids and proposals. •Forecast project’s monthly spending. •Commissioning Sterilizer projects through FAT, SAT, IQ/OQ, and PQ phases •Write FAT, SAT, and IQ/OQ validation protocols. •Execute IQ/OQ and PQ validation. •Lead sterilization technicians, and support team members during IQ/OQ validation. •Work with Quality Engineering (QE) and Quality Assurance (QA) to comply with SOP procedures. •Knowledge of the CCR, CSCR, Isolation plan, Master Validation Plan (MVP) procedures. •Knowledge of P & ID drawing, Schematic drawing, Process Flow Diagram, and Pneumatic system. •Understand Sterilizer pressure vessel, PLC Sterilization control systems, and heat exchanger systems. •Knowledge of Sterilization PM, Spare Part systems, and Sterilizer’s calibration processes. •Negotiate with contractors/vendors on job bids/proposals.to acquire the lowest possible bid for the •Hold kick-off meetings, coordination meetings, and weekly meetings. •Write Project Summary Reports to close out IQ/OQ validation. •Interface with various vendors/manufactures to review and approve equipment specifications. •Involve closely with Sterilization process engineers to design process improvements. •Investigate and analyze root cause of sterilization processes. Implement Corrective Actions. •Investigate and analyze root cause of equipment failures. Implement Corrective Actions. •Provide technical supports to Sterilization manufacturing. •Train sterilization technicians, mechanics, and floor operators. •Support sterilization manufacturing for production Start-up, Sustaining & Re-qualification.