Senior Scientist, R&D Microbiology

Irvine, California, US
Apr 28, 2021
May 11, 2021
Employment Type
Full time
Salary Type
Advanced Sterilization Products (ASP), a Fortive operating company is looking for a Senior Scientist, R&D Microbiology to use knowledge of scientific techniques to design and develop safe and effective company products in compliance to new product development procedures.

The primary responsibilities will be to perform or direct the execution of the following activities:

Initiate research projects to evaluate the development and assessment of new technologies for potential products following the regulatory guidelines (FDA, TGA, ISO etc).
Prepare and execute protocols / research studies to support product development from feasibility to final product verification / validation.
Analysis of situation / data and in-depth evaluation of various identifiable factors in the areas of microbiology, biocompatibility, antimicrobial, disinfection and sterilization efficacy.
Ensures quality of projects including desing, execution, data summary and interpretation / review adhere to GDP and applicable regulations.
Effective communication of project status / results to others.
Prepare and review written information to provide products support.
Oversee microbiology laboratory equipment validation program.
May provide guidance and work direction to lwer level research scientists and provide support to OOS and CAPA investigations as needed.
Train other laboratory personnel in execution of testing procedures.
Provide support to other programs and project teams requiring technical expertise
Lead technicians in support of R&D activities
Ability to work with cross functional teams to reach consensus.
Work in teams focused on identifying and implementing process level efficiencies
Maintain awareness of the advances and needs in sterilization / disinfection, microbiology and biocompatibility
Meet and ensure adherence to compliance standards including monitoring, compliance with the relevant guidance documents, such as from ISO and FDA, and in preparation of documentation demonstrating compliance
Expect to challenge and motivate colleague to reach their highest potential; create an environment that encourages risk-taking; promote teamwork; encourage others to pursue challenging goals and to challenge the status quo; and foster continuous professional development and career growth of a diverse workforce.

Minimum experience and education for this position:

Bachelor's degree in a scientific discipline, such as Biology or Microbiology or a closely related field AND 5 years of applicable experience OR a Master's degree AND 3-5 years of applicable experience OR a PhD AND 0-2 years of applicable experience.
At least 1 year of experience in the Medical Device or other GxP-regulated industry;
At least 2 years in laboratory or related environment;
Professional experience and understanding of QSR, FDA, and ISO guidelines is required.

Our ideal candidate will be/possess:

Knowledge of sterilization, disinfection and cleaning technologies for reprocessing of medical devices is required
Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines is required
Strong understanding of compliance with applicable laboratory and safety procedure is required
The successful candidate must be self-driven, innovative, 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
Demonstrated experience working with medical washer-disinfectors or sterilizers intended for reprocessing of medical devices is preferred
Demonstrated 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

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