Senior Scientist (Wednesday - Saturday)

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...