Duties and Responsibilities

Under general direction with limited supervision and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

Lead liquid culture (fermentation) process development and implementation Lead studies for enzyme purification and activity control  Work closely with manufacturing engineers to integrate biological indicator manufacturing processes and systems 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 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 Identify, perform experiments, and implement process, cost, yield, scrap, etc. improvements to biological indicator manufacturing process in collaboration with operations department Execute product and test method development and validation, in support of production commercialization for medical device reprocessing and infection control projects Train and provide guidance to junior-level scientists either under direct or indirect supervision 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 Performs other duties assigned as needed

Other Duties

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

Qualifications - Education & Experiences

Minimum experience and education for this position is a bachelor’s degree with 7-9 years of applicable experience in a scientific discipline such as Microbiology, Biochemistry, Biomedical Engineering or a closely related field, or a master’s degree with 5-7 years of applicable experience, or a PhD with 2-4 years of applicable 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 At least 2 years of supervisory experience with one or more direct reports strongly preferred Additional experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements preferred Professional experience and understand of QSR, FDA, and ISO guidelines preferred

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations: 

Fermentation on microbial liquid culture in bioreactors and its upstream and downstream process (filter purification) 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 Experience working in a regulated industry, where design controls per FDA Quality System Regulations and ISO 13485 are applied 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). Sounds 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) 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 skills as well as demonstrate the ability to effectively function in a cross-functional team environment

Responsibilities for Others and Internal Interactions

This person may supervise or train junior scientists Collaborate with Operations, Quality Assurance, Supply Chain, and Regulatory Affairs partners

External Interactions 

Ability to elevate inquiries from customers of ASP, government agencies or auditors, when occurs, per ASP standard operating procedures Leads communication with external suppliers, service providers, and manufacturers Collaborates with external laboratories to form study plans, execute the studies, and analyze the results Supports VOC (voice of customers) collection and translates VOC to generate product concept

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.