Staff Scientist

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.ResponsibilitiesUnder 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 implementationCollaborate 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 projectsLead R&D and life cycle management activities; provide guidance to other scientists as neededLead design changes for marketed products such as manufacturing steps, process, or design validations, product testing, marketing analysis ensuring robust processes that meet CTQsWork closely with manufacturing engineers to integrate biological indicator manufacturing processes and systemsLead 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 proceduresProvide 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 improvementsPrepare 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 neededEducationMinimum 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 experienceRelated ExperienceAt least 7 years of experience in the Medical Device or other GxP-regulated industry preferredAt least 5 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions preferredAdditional experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements preferredProfessional experience and understanding of QSR, FDA, and ISO guidelines preferredKnowledge and SkillsFermentation on microbial liquid culture and its upstream and downstream process experience are strongly preferredHands-on experience supporting bacterial endospore production, biological indicator manufacturing and terminal sterilization, and a thorough understanding of microbiology sterilization principles is preferredCapability 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 preferredCapability 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 sterilizationDemonstrated experience in process development and/or validation preferred Knowledge of analytical techniques and experience with analytical method development, validation, and transfer preferredGreen Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferredThe 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 partnersFortive Corporation OverviewFortive'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 View email address on click.appcast.io. Bonus or EquityThis position is also eligible for bonus as part of the total compensation package.Pay RangeThe salary range for this position (in local currency) is 131,215 - 219,075Department:Science