Job Category:
Research and Development
QMS Impact Category: Direct
Position Summary
The Scientist II, Chemistry, works under moderate supervision and uses knowledge of scientific techniques to contribute on design and development of safe and effective company products in compliance to new product development procedures.
Duties and Responsibilities
Under moderate supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
Plans and executes experiments/project tasks in support of new technologies associated with cleaning and disinfection or sterilization of medical instruments.
Demonstrates research and development techniques; independently determines how to set up and execute experiment and analysis.
Follows prepared protocols and designed experiments to execute research studies under limited supervision to support product development from feasibility to final product verification/validation.
Performs routine and complex testing in compliance with laboratory test methods and procedures to support timely delivery of the tasks related to the new product development and product life cycle management.
Conducts qualitative and quantitative chemistry analysis of raw materials and finished goods.
Develops appropriate protocols, executes the study, performs data organization and data analysis, and prepares report.
Supports 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.
Participates and supports in new product development project through feasibility work to pilot production.
Communicates effectively and comprehensively experiment status/testing results to others.
Supports and coordinates equipment qualifications and maintains laboratory instruments in their qualified state as well as troubleshoots instrumentation in the event of instrument issues.
Supports OOS, NC and CAPA investigations to higher level scientists as needed.
Provides training to other laboratory personnel in execution of testing procedures.
Responsible for communicating business related issues or opportunities to next management level.
Performs other duties assigned as needed.
Other Duties:
Provides support to other programs and project teams that require chemistry test and technical expertise.
Supports team focused on identifying and implementing process level efficiencies.
Contributes to building extra ordinary team environment.
Meets and ensures adherence to compliance standards including monitoring, and compliance with the relevant guidance documents, such as the ones from ISO and FDA.
Provides initial review of data generated by peers and contract laboratories.
Qualifications
Bachelor's or Master's degree in Chemistry, or a closely related field.
Years of Related Experience:
A Bachelor's Degree in Chemistry or closely related field with more than 3 years of applicable experience, or Master's Degree in Chemistry or closely related field with 0-3 years of applicable experience.
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
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 preferred.
Knowledge and experience of formulation chemistry and design of experiment (DOE) is preferred.
Excellent hands-on experience in the R&D chemistry laboratory is required.
A strong knowledge of analytical chemistry techniques is required.
Knowledge and experience of analytical method development, validation, and transfer is preferred.
Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines is preferred.
Experience in validation or qualifying instruments in the GxP-regulated industry is preferred.
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 detergents, sterilants, and disinfectants 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.
Responsibility for Others and Internal Interactions
Works effectively with cross-functional teams
External Interactions
Ability to elevate inquiries from customers of ASP, government agencies or auditors, when occurs, per ASP standard operating procedures
Supports communication with external suppliers, service providers, and manufacturers.
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.