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 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. 

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.