Sr. Scientist at Fortive

Irvine, California, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Jan, 26

Salary

0.0

Posted On

10 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, Spore Culture Techniques, Team Management, Project Management, Quality Assurance, FDA Guidelines, ISO Standards, Statistical Analysis, Process Development, Analytical Method Development, Technical Operations, Technical Transfer, Lean, Six Sigma, GxP Regulations, Biological Indicator Manufacturing

Industry

electrical;Appliances;and Electronics Manufacturing

Description

Scientist to oversee and manage the day-to-day operations activities of Biological Indicators (BI) production lab. The successful candidate will be responsible for leading activities related to spore culture production, ensuring the highest standards of quality and efficiency. This role requires a strong background in microbiology, experience in spore culture techniques, and the ability to manage teams, activities, and projects in a fast-paced production environment. 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 5 - 7 years of applicable experience, or a master's degree with 3 - 5 years of applicable experience, or a PhD degree with 0 - 2 years of applicable experience At least 4 years of experience in the Medical Device or other GxP-regulated industry preferred At least 2 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 Proven experience in leading and managing laboratory activities, teams, and projects 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. stability testing). Sounds statistical analysis is required (i.e., Minitab, etc.) 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 Lead day-to-day activities of the BI production lab including resource planning, Daily Management, ensuring smooth workflow and adherence to production schedules and meeting KPI targets Develop, improve, and implement standard operating procedures (SOPs) for spore culture production and related activities. Mentor and train laboratory Scientists and Biotechnicians, providing guidance and support in their daily tasks. Lead process changes for Biological Indicator production such as manufacturing steps, process, or equipment validations, product testing, ensuring robust processes that meet CTQs Monitor and maintain laboratory equipment to ensure optimal performance and compliance with safety and regulatory standards. Work closely with manufacturing engineers to integrate biological indicator manufacturing equipment, processes, and systems Manage laboratory studies, projects, and processes/initiatives as well as initiates and completes technical reports Lead and document technical investigations, NCs, or CAPAs associated with biological indicator or other consumable processes, systems, or products according to GMP principals and procedures Demonstrate proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and lead process and business improvement activities Be responsible for communicating business related issues or opportunities to next management level Performs other duties assigned as needed Prepare and assist of strategic vision or plan by collaborating with other cross functional departments Represent production lab in Kaizens, workshops, PSP, and other problem solving and improvement 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 This person may supervise or train junior scientists and lab technicians Collaborate with Quality Assurance, Supply Chain, and Regulatory Affairs partner

Responsibilities

The Sr. Scientist will oversee the day-to-day operations of the Biological Indicators production lab, ensuring quality and efficiency in spore culture production. This role includes leading laboratory activities, managing teams, and developing standard operating procedures.