Scientist II

Advanced Sterilization Products; Irvine (CA); On-site; USD 81,000 - 136,000; Full time

Job summary

Advanced Sterilization Products is seeking a Scientist II in R&D Biochemistry & Microbiology to support NPD and sustaining BI production. You will work under supervision to develop procedures, test enzymes, culture microbes, and validate processes for sterilization and reprocessing applications.

Collaboration with cross-functional teams is essential to meet CTQ targets and regulatory standards. The role emphasizes microbial fermentation, process validation, and lifecycle management, with

Qualifications

• Bachelor’s degree in Microbiology, Biochemistry, Biomedical Engineering or related field with 3–5 years of experience.
• MS in Microbiology or equivalent with 0–2 years of applicable experience.
• Experience in Medical Device or other GxP-regulated industry.
• Experience with IQ/OQ/PQ and PV processes preferred.

Responsibilities

• Assist development and validation for NPD and BI production.
• Support microbial fermentation development and commercialization.
• Support lifecycle management and CAPA investigations.
• Ensure compliance with ISO and FDA guidance and documentation.

Skills

Biochemistry

Microbiology

Six Sigma

Lean

IQ/OQ/PQ

PV processes

Education

Bachelor’s degree in Microbiology/Biochemistry/Biomedical Engineering

MS degree in Microbiology

Tools

Analytical methods

Job description

The Scientist II, R&D Biochemistry and Microbiology (B&M), primarily supports projects for new product development (NPD), and assists life cycle management (LCM) activities, with sustaining product related projects for ASP products in alignment of company’s strategic plan under the leaderships of both R&D and Operations in close collaboration with the cross-functional manufacturing team.Duties and ResponsibilitiesUnder supervision of manger or general direction, and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:Support projects, activities, and applications related to principles of biochemistry and microbiology from R&D, operations, and QA with focuses on development and improvement of procedures for NPD and sustaining biological indicator (BI) productionBiochemical and Microbiological activities include analyses of enzymes, liquid culture for BI production, and analytes from cultivation, production, and application of microorganismsAssist microbial fermentation development and commercializationSupport design changes for marketed products such as manufacturing steps, process or design validations, product testing, marketing analysis ensuring robust processes at suppliers that meet CTQ’sWork closely with manufacture engineers to integrate ASP product manufacturer process and systemsDemonstrate 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 improvementsSupport life cycle management activities for consumable medical device products as well as any associated NC or CAPA investigationsProvide support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiologyAssist of strategic vision or plan by collaborating with other cross functional departmentsCommunicate business related issues to management timelyPerforms other duties assigned as neededBe responsible for communicating business related issues or opportunities to next management levelPerforms other duties assigned as neededOther DutiesExecute of product development and validation, in support of production commercialization for medical device reprocessing and infection control projectsMeet 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 complianceEducationMinimum 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 with 3 – 5 years of experience, orMS degree in Microbiology or equivalence with 0 – 2 years of applicable experienceYears of Related Experience:At least 2 years of experience in the Medical Device or other GxP-regulated industryAt least 2 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positionsAdditional experience and familiarity with IQ/OQ/PQ and PV processes and requirements preferredExperience in microbial fermentation preferredKnowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)Capability to execute study protocols, analyze data, and propose theoretical solutions/explanations for reprocessing and sterilization of medical devices or Biological Indicator manufacturing studies (e.g., D-value, stability testing).Hands on testing experiences for Biological Indicator (BI) manufacturing (e.g., titers, D-value, stability testing) and sterilization (e.g., cycle validation) are preferredExperience on company operation related with bacterial endospore production, Biological Indicator (BI) manufacturing, medical device reprocessing, and terminal sterilization as well as a thorough understanding of microbiology sterilization/disinfection principles are preferredCapability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, and quality engineering etc.)Demonstrated experience in process development and/or validationKnowledge of analytical techniques and experience with analytical method development, validation, and transferThe successful candidate must be self-driven, innovative, have strong critical thinking and problem-solving skills, and capable of working independently or in a teamMust possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environmentComplianceAll employees have a duty to comply with applicable laws, regulations, standards, ASP policies and procedures.This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.Fortive 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 ProductsASP 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 [e-mail] 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 81,190 - 135,585ASP 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 [e-mail] salary range for this position (in local currency) is 81,190 - 135,585This position is also eligible for bonus as part of the total compensation package.