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Staff Scientist

Fortive Corporation

Irvine, CA

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JOB DETAILS
SALARY
$131,215–$219,075 Per Year
SKILLS
Analysis Skills, Analytical Method Development, Analytical Method Validation, Association for the Advancement of Medical Instrumentation (AAMI), Biochemistry, Biological Processes, Biomedical Engineering, Business Intelligence, Business Solutions, Business Strategy, Change Management, Chemistry, Communication Skills, Cross-Functional, Data Analysis, Documentation, Environmental Health, FDA (Food and Drug Administration), FDA Requirements, Fermentation, GMP (Good Manufacturing Practices), Government Regulations, GxP, Healthcare, Hospital, ISO (International Organization for Standardization), Infection Control, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Engineering, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Microbiology, Microsoft Active Server Page (ASP), Minitab, Patient Care, People Management, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Improvement, Process Validation, Product Design, Product Development, Product Marketing, Product Support, Product Testing, Product/Service Launch, Production Support, Protocol Analysis, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Research & Development (R&D), Research Protocols, Safety/Work Safety, Sales, Startup, Statistics, Sterilization, Strategic Planning, Supply Chain, Support Documentation, Team Player, Technical Operations, Technical Writing, Test Plan/Schedule, Time Management, Vision Plan, Writing Skills
LOCATION
Irvine, CA
POSTED
4 days ago
The Staff Scientist is responsible for R&D life cycle management (LCM) activities and projects pertaining to biological indicator (BI) products; lead new and sustaining product related projects for ASP products in support of the company’s strategic plan.


Responsibilities


Under general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, the primary responsibilities of this position will be to perform or direct the execution of the following activities:


+ Lead liquid culture for microbial fermentation process development and implementation

+ Collaborate on the studies for enzyme purification and activity control with biochemistry SME

+ Execute product and test method development and validation, in support of production commercialization for medical device reprocessing and infection control projects

+ Lead R&D and life cycle management activities; provide guidance to other scientists as needed

+ Lead design changes for marketed products such as manufacturing steps, process, or design validations, product testing, marketing analysis ensuring robust processes that meet CTQs

+ Work closely with manufacturing engineers to integrate biological indicator manufacturing processes and systems

+ Lead or support and document technical investigations, NCs, or CAPAs associated with biological indicator or other consumable processes, systems, or products according to GMP principals and procedures

+ Provide support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiology (e.g., biological indicator)

+ Demonstrate proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements

+ Prepare and assist of strategic vision or plan by collaborating with other cross functional departments

+ Communicate business related issues to management timely

+ Meet and ensure adherence to compliance standards including monitoring, compliance with the relevant guidance documents from such as ISO, QSR or FDA, and in preparation of documentation demonstrating compliance

+ Perform other duties assigned as needed


Education


Minimum experience and education for this position is a bachelor’s degree in a scientific discipline, such as Microbiology, Biochemistry, Biomedical Engineering or a closely related field, and 7-9 years of applicable experience, or a master’s degree with 5-7 years of applicable experience, or a PhD with 2-4 years of applicable experience


Related Experience


+ At least 7 years of experience in the Medical Device or other GxP-regulated industry preferred

+ At least 5 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions preferred

+ Additional experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements preferred

+ Professional experience and understanding of QSR, FDA, and ISO guidelines preferred


Knowledge and Skills


+ Fermentation on microbial liquid culture and its upstream and downstream process experience are strongly preferred

+ Hands-on experience supporting bacterial endospore production, biological indicator manufacturing and terminal sterilization, and a thorough understanding of microbiology sterilization principles is preferred

+ Capability to develop study protocols, analyze data, and propose theoretical solutions/explanations for sterilization or biological indicator manufacturing studies (e.g., D-value, stability testing). Sound statistical analysis is required (i.e., Minitab, etc.); Provide guidance and supervisory role to microbiology associates conducting hands-on testing for Biological Indicator manufacturing (e.g., titers, D-value, stability testing) or sterilization (e.g., D-value and cycle validation)

+ Experience working in a regulated industry, where design controls per FDA Quality System Regulations and ISO 13485 are applied is preferred

+ Capability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, quality engineering, etc.)

+ Knowledge AAMI/ISO standards in the area of biological indicators and/or terminal sterilization

+ Demonstrated experience in process development and/or validation preferred

+ Knowledge of analytical techniques and experience with analytical method development, validation, and transfer preferred

+ Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred

+ 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

+ This person may supervise or train junior scientists

+ Collaborate with Quality Assurance, Supply Chain, and Regulatory Affairs partners


Fortive Corporation Overview


Fortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.


We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. 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 advanced technologies that help providers focus on exceptional patient care.


We are a diverse team 10,000 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.


At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.


Fortive: For you, for us, for growth.


About Advanced Sterilization Products


ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.


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.


Bonus or Equity

This position is also eligible for bonus as part of the total compensation package.


Pay Range

The salary range for this position (in local currency) is 131,215 - 219,075


This position is also eligible for bonus as part of the total compensation package.


The salary range for this position (in local currency) is 131,215 - 219,075
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.

About the Company

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Fortive Corporation