Senior Scientist Advanced Sterilization Products Irvine, CA, United Stat

Position: Senior Scientist (Wednesday - Saturday) Advanced Sterilization Products Irvine, CA, United Stat[...]
## Senior Scientist (Wednesday - Saturday)
Irvine, CA, United States Job ID9840

Company Advanced Sterilization Products
** Shift: Wednesday - Saturday
***
* Location:

** Irvine, CA
** Key Responsibilities
**** Operational & Manufacturing Leadership
*** Support the BI Lab in managing day‐to‐day operations related to manufacturing, materials, facilities, scheduling, engineering, and maintenance to ensure smooth, continuous, cost‐effective, and controlled production
* Plan, prepare, issue, and control production schedules and material requirements to ensure timely availability of approved materials aligned with production forecasts and inventory goals
* Serve as shift or operational lead as required to maintain production execution, area readiness, and GMP compliance
** Production Support
*** Perform hands‐on production and testing activities as needed to support execution, training, troubleshooting, or elevated business demand
* Apply scientific techniques to culture and test spores used in the biological indicator manufacturing process
* Prepare, review, and technically assess batch records in accordance with cGDP
** Technical Leadership & Troubleshooting
*** Lead and support complex product deviations, process excursions, and production issues using scientific, technical, and statistical diagnostic methods
* Apply standard scientific principles, theories, and concepts to evaluate process performance and implement corrective and preventive actions
* Provide developmental and technical support for both new and existing products
** Process Development, Optimization & Improvement
*** Identify opportunities to improve existing processes, systems, and equipment to increase efficiency, improve quality, and reduce cost
* Design, execute, and interpret experiments to optimize manufacturing processes and reduce variability
* Lead or co‐lead Kaizens and other continuous improvement initiatives
* Monitor process performance metrics and ensure sustained improvements through data‐driven decision making
** Education and Experience Requirements
*** Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemical Engineering, or a related scientific discipline required
* Master’s Degree preferred
* 4–8+ years of experience in a regulated biologics or medical device manufacturing environment
* Demonstrated experience leading technical projects, investigations, or cross‐functional initiatives
* Experience with process development, process improvement, and operational support in manufacturing environments
** Required Knowledge & Skills
*** Advanced knowledge of cGMP and cGDP requirements
* Strong experience working in FDA‐regulated environments and Medical Device manufacturing
* Expertise in aseptic processing and biologics manufacturing
* Ability to design experiments, analyze data, and interpret results
* Strong written and verbal communication skills
* Proficiency with Excel and data analysis tools
* Preferred Qualifications
* Knowledge of SAP inventory management systems
* Experience with statistical tools (e.g., Minitab)
* Yellow Belt or Green Belt certification (Black Belt a plus)
* Train‐the‐Trainer or Training Within Industry (TWI) experience
* Knowledge of process control systems and automation
** Work Environment &

Physical Requirements
*** Domestic travel up to approximately 10%
* On‐call or weekend support may be required
* Ability to lift 31–50 lbs
* Ability to wear required PPE
* Ability to work in a manufacturing laboratory environment
** Fortive Corporation Overview
** Fortive'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…