Scientist II

Socket.dev; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

ASP is seeking a Scientist II in R&D Biochemistry and Microbiology to support new product development and life cycle management for ASP products. The role requires collaboration with R&D, Operations and QA to develop and validate biosciences processes and ensure compliant manufacturing and testing.

The position emphasizes biochemical and microbiological analyses, microbial fermentation support, and design changes to ensure robust processes meeting CTQs, ISO and FDA expectations, with a

Qualifications

• Degree(s) in a scientific discipline with 3–5 years in Medical Device or GxP-regulated industry.
• Experience with IQ/OQ/PQ and PV processes is preferred.
• Strong analytical and problem-solving skills; able to work independently or in a team.

Responsibilities

• Support NPD and life cycle management for ASP products; assist in BI production and related analyses.
• Conduct biochemical and microbiological analyses, including enzyme analyses and fermentation development.
• Assist design changes, validations, testing, and supplier process robustness.
• Collaborate with cross-functional teams (R&D, Operations, QA) and communicate issues to management.

Skills

Biochemistry

Microbiology

Six Sigma

Lean

Analytical methods

Process development

QA / GMP knowledge

Education

Bachelor’s degree in Microbiology or Biochemistry or Biomedical Engineering (or related field)

MS in Microbiology or equivalent

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 Responsibilities

Under 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) production
• Biochemical and Microbiological activities include analyses of enzymes, liquid culture for BI production, and analytes from cultivation, production, and application of microorganisms
• Assist microbial fermentation development and commercialization
• Support 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’s
• Work closely with manufacture engineers to integrate ASP product manufacturer process and systems
• 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
• Support life cycle management activities for consumable medical device products as well as any associated NC or CAPA investigations
• Provide support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiology
• Assist of strategic vision or plan by collaborating with other cross functional departments
• Communicate business related issues to management timely
• Performs other duties assigned as needed
• Be responsible for communicating business related issues or opportunities to next management level
• Performs other duties assigned as needed

Other Duties

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

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 with 3 – 5 years of experience, or
• MS degree in Microbiology or equivalence with 0 – 2 years of applicable experience

Years of Related Experience

• At least 2 years of experience in the Medical Device or other GxP-regulated industry
• At least 2 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions
• Additional experience and familiarity with IQ/OQ/PQ and PV processes and requirements preferred
• Experience in microbial fermentation preferred

Knowledge, 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 preferred
• Experience 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 preferred
• Capability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, and quality engineering etc.)
• Demonstrated experience in process development and/or validation
• Knowledge of analytical techniques and experience with analytical method development, validation, and transfer
• 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

Compliance

All 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 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.

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 ASP

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 [e-mail].