Medtronic Sr Microbiologist in Singapore, Singapore
Singapore, Singapore, Singapore
Jul 10, 2017
·Own microbiological control process : Bioburden, Endotoxin, Microbiological analysis (liquid, air, surfaces) and Microbiological identification
·Work with Sterilization Engineer to provide support and testing.
·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
oFollowsCEAindicators (Temperature, Pressure, Particles, air and surfaces contamination, purified water contamination, etc.)
·Bachelor Degree in Life Science (Microbiology, Biotechnology, Pharmacist, or equivalent)