Biology/Microbiology Associate - Fortive Corporation
Irvine, CA
About the Job
Senior Scientist, R&D Technical Business Solutions
Description
Senior Scientist, R&D Technical Business Solutions will work under limited supervision and use knowledge of scientific techniques to validate and qualify medical instruments for reprocessing in ASP sterilization and disinfection systems, support designing and development of new sterilization or disinfection cycles / products in compliance to ASP procedures, and support other complex projects requiring cross-functional collaborations.
Responsibilities
Under supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures, and guidelines, this position:
+ Plans and executes research projects associated with terminal sterilization / disinfection of medical instruments.
+ Manages laboratory studies, projects, and processes/initiatives as well as initiates and completes technical reports.
+ Conducts qualitative and quantitative analysis, performs data organization, and in-depth data analysis. Prepares technical presentations and technical reports.
+ Collaborates with Medical Device Manufacturers to design, conducts and interprets experiments to support validation and qualification of their medical devices for reprocessing in ASP sterilization and disinfection systems.
+ Supports lifecycle management activities for ASP capital and consumable medical device products as well as any associated NC or CAPA investigations. Ensures quality of projects including design, execution, data summary and interpretation, and report preparation/review adherent to applicable regulations and Good Documentation Practices.
+ Oversees, performs and/or coordinates equipment qualifications and maintains laboratory instruments in their qualified state as well as troubleshoots instrumentation in the event of instrument issues.
+ Develops solutions to problems of moderate scope and complexity through the exercise of judgment within defined practices and policies to determine appropriate actions.
+ Works independently to plan, conduct, and manage multiple research projects to meet department and company objectives. Communicates business related issues or opportunities to next management level.
+ May coordinate/review work of others, provide instructions, and supervise lower-level scientists.
Qualifications
Minimum of a Bachelor Degree in Microbiology, Biology or related field with 5+ years of applicable experience.
Master’s Degree in Microbiology, Biology or related field with 3+ years of applicable experience.
Ph.D. in Microbiology, Biology, or related field with 0-2 years of applicable experience.
+ A strong knowledge of microbiology techniques is required.
+ 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.
+ Working experience with sterilants and disinfectants is preferred.
+ Experience of providing instruction to professional and technical employees on projects and initiatives is preferred
+ Ability to elevate inquiries from customers, government agencies or auditors, when occurs, by following standard operating procedures is preferred.
+ The successful candidate must be self-driven, have strong critical thinking and problem-solving skills, capable of working independently or in a team, and must possesses the ability to effectively function in a cross-functional team environment.
Fortive Corporation Overview
Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.
We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.
At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
Fortive: For you, for us, for growth.
The salary range for this position (in local currency) is 79,700.00 - 147,900.00. Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.
We are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
Description
Senior Scientist, R&D Technical Business Solutions will work under limited supervision and use knowledge of scientific techniques to validate and qualify medical instruments for reprocessing in ASP sterilization and disinfection systems, support designing and development of new sterilization or disinfection cycles / products in compliance to ASP procedures, and support other complex projects requiring cross-functional collaborations.
Responsibilities
Under supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures, and guidelines, this position:
+ Plans and executes research projects associated with terminal sterilization / disinfection of medical instruments.
+ Manages laboratory studies, projects, and processes/initiatives as well as initiates and completes technical reports.
+ Conducts qualitative and quantitative analysis, performs data organization, and in-depth data analysis. Prepares technical presentations and technical reports.
+ Collaborates with Medical Device Manufacturers to design, conducts and interprets experiments to support validation and qualification of their medical devices for reprocessing in ASP sterilization and disinfection systems.
+ Supports lifecycle management activities for ASP capital and consumable medical device products as well as any associated NC or CAPA investigations. Ensures quality of projects including design, execution, data summary and interpretation, and report preparation/review adherent to applicable regulations and Good Documentation Practices.
+ Oversees, performs and/or coordinates equipment qualifications and maintains laboratory instruments in their qualified state as well as troubleshoots instrumentation in the event of instrument issues.
+ Develops solutions to problems of moderate scope and complexity through the exercise of judgment within defined practices and policies to determine appropriate actions.
+ Works independently to plan, conduct, and manage multiple research projects to meet department and company objectives. Communicates business related issues or opportunities to next management level.
+ May coordinate/review work of others, provide instructions, and supervise lower-level scientists.
Qualifications
Minimum of a Bachelor Degree in Microbiology, Biology or related field with 5+ years of applicable experience.
Master’s Degree in Microbiology, Biology or related field with 3+ years of applicable experience.
Ph.D. in Microbiology, Biology, or related field with 0-2 years of applicable experience.
+ A strong knowledge of microbiology techniques is required.
+ 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.
+ Working experience with sterilants and disinfectants is preferred.
+ Experience of providing instruction to professional and technical employees on projects and initiatives is preferred
+ Ability to elevate inquiries from customers, government agencies or auditors, when occurs, by following standard operating procedures is preferred.
+ The successful candidate must be self-driven, have strong critical thinking and problem-solving skills, capable of working independently or in a team, and must possesses the ability to effectively function in a cross-functional team environment.
Fortive Corporation Overview
Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.
We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.
At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
Fortive: For you, for us, for growth.
The salary range for this position (in local currency) is 79,700.00 - 147,900.00. Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.
We are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
Source : Fortive Corporation