Medtronic Sr Microbiologist in Singapore, Singapore

Sr Microbiologist

Location:

Singapore, Singapore, Singapore

Requisition #:

17000ACK

Post Date:

Jul 10, 2017

Main Purpose:

·Own microbiological control process : Bioburden, Endotoxin, Microbiological analysis (liquid, air, surfaces) and Microbiological identification

·CEA Administrator

·Work with Sterilization Engineer to provide support and testing.

Key Accountabilities:

·Supervise the microbiological testing process:

oEnsure alignment to all microbiological testing requirements per FDA, TUV,ISO13485 regulations / standards

oQualify / validate microbiological testingprocess and equipment

oEnsure follow-up of all testing equipment to ensurecompliance activities

oEnsure validation for the product to meet microbial requirement.

oIn collaboration with Global Sterilization and Microbiology team, lead / support process / equipment qualification activities and microbiological testing improvements

oAlign manufacturing processes to all global sites by contributing to the global process development and qualification protocols and execution

oTrain technical support

oSupport production activities tasks (technical support, non-conformity management, continuous improvement)

oLead / perform microbiological OOS (out of specification) analysis and CAPA actions.

oSupport / Lead Operation Excellence initiatives among high volume facilities

·Supervise/Act for local microbiological activities

oAct for sampling and executing laboratories control : Bioburden, Endotoxin,Microbiologicalanalysis (liquid, air, surfaces), Microbiological identification

oLead microbiological tasks to support sterilization validation activities

·SuperviseCEAactivities

oFollowsCEAindicators (Temperature, Pressure, Particles, air and surfaces contamination, purified water contamination, etc.)

oElaborateCEAreports

Qualifications:

·Bachelor Degree in Life Science (Microbiology, Biotechnology, Pharmacist, or equivalent)