As part of the R&D Media Program, the Scientist 1 will prepare media and fluids for microbial testing. Test growth promotion and sterility to release media and perform enzyme activity assays. The scientist will wash, prepare and sterilize glassware and laboratory supplies to meet demand and maintain laboratory and media preparation inventory. The individual will also support equipment validation, investigations, research studies and protocols.
Responsibilities:
Under supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
Prepares microbiology media, fluids, and enzyme solution and performs release testing (growth promotion, sterility, and enzyme activity assay)
Washes, sterilizes glassware & laboratory supplies as needed for experiments, and maintains laboratory and media preparation inventory
Generates media record documentation following good documentation practices
Supports microbiology laboratory equipment validation program
Must be able to provide training to other laboratory personnel in execution of testing procedures
Performs preparation & release of biological indicators for microbial tests
Responsible for communicating business related issues or opportunities to next management level
Performs experiments to evaluate the development and assessment of new technologies for potential products following the regulatory guidelines / standards (FDA, TGA, ISO etc.)
Demonstrates research and development techniques
Follows prepared protocols and designed experiments to execute research studies under supervision to support product development from feasibility to final product verification / validation
Effectively communicates experiment status / testing results to others
Performs data organization and data analysis and prepares basic report
Supports OOS and CAPA investigations to higher level scientists as needed.
Support to develop solutions to problems of limited to moderate scope and complexity through the exercise of judgment within defined practices and policies to determine appropriate action
Requires a limited to full use of application of basic to standard principles, theories, concepts, and techniques
Performs other duties assigned as needed
Qualifications:
0-2 years in laboratory experience with Bachelor's Degree in a scientific discipline, such as Microbiology, Biology, or a closely related field
Strong understanding of compliance with applicable laboratory and safety procedure is required
The successful candidate must be self-driven, have strong critical thinking and problem-solving skills, and capable of working independently or in a team
Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment
Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines is preferred
Knowledge of sterilization, disinfection, and cleaning technologies for reprocessing of medical devices is strongly preferred
Working experience with medical sterilizers intended for reprocessing of medical devices is preferred
Experience in validation or qualifying medical devices for reprocessing in medical sterilizers is preferred
Working knowledge of designs and features of medical devices is preferred
Able to handle minimum of 10 lbs. of load to process sterilization cycles
Fortive Corporation Overview
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