Scientist I, R&D Biology/Microbiology

Responsibilities:

Use knowledge of scientific techniques to contribute on design and develop safe and effective company products in compliance to new product development procedures.

Under supervision & general direction, and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

• Expected to perform experiments to evaluate the development and assessment of new technologies for potential products following the regulatory guidelines (FDA, TGA, ISO etc.)
• Expected to demonstrate research and development techniques
• Follow prepared protocols and designed experiments to execute research studies under supervision to support product development from feasibility to final product verification / validation
• Performs data organization and data analysis and prepares basic report
• Performs preparation & release of biological indicators for microbial tests
• Prepare microbiology media/fluids to be used in experiments, disinfect, wash, & sterilize glassware and supplies needed for experiments
• 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
• Effectively communicates experiment status / testing results to others
• Requires a limited to full use of application of basic to standard principles, theories, concepts and techniques
• Trains others on testing techniques
• Supports microbiology laboratory equipment validation program.
• Supports OOS and CAPA investigations to higher level scientists as needed.
• Must be able to provide training to other laboratory personnel in execution of testing procedures.
• Responsible for communicating business related issues or opportunities to next management level
• Provide support to other programs and project teams requiring testings
• Support in teams focused on identifying and implementing process level efficiencies
• Support in maintaining awareness of the advances and needs in sterilization / disinfection, microbiology and biocompatibility
• Use and adhere to standard principles and compliance with the relevant guidance documents, such as from ISO and FDA, and in preparation of documentation demonstrating compliance
• Contribute to building extra ordinary team environment

Qualifications:

• Bachelors Degree in a scientific discipline. such as Microbiology, Biology, or a closley related field
• 0-2 years in laboratory or related environment
• Strong understanding of compliance with applicable laboratory and safety procedure is required
• Knowledge of sterilization, disinfection and cleaning technologies for reprocessing of medical devices is strongly preferred
• Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines is preferred
• 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
• Working experience with sterilants and disinfectants is preferred
• Working experience with medical washer-disinfectors or sterilizers intended for reprocessing of medical devices is preferred
• Experience in validation or qualifying medical devices for reprocessing in medical washer-disinfectors or sterilizers is preferred
• Working knowledge of designs and features of medical devices is preferred

Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose: to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress. Here, you get the excitement of a "startup" with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth. There's no limit to what you can learn, or the impact you can make: for you, for us, for growth.

Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.

"The company in which you have expressed employment interest is a subsidiary or affiliate of Fortive Corporation. The subsidiary or affiliate is referred to as a Fortive Company. Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, ancestry, sex (including pregnancy, childbirth and related medical conditions), age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity or expression, and other characteristics protected by law.