Senior Scientist

Position: Senior Scientist (Wednesday - Saturday)
Shift: Wednesday - Saturday

Location:

Irvine, CAKey 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 cGDPTechnical 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 preferred4–8+ 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 PPEAbility 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 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…