Location: Irvine, CA
Shift: Wednesday - Saturday
Key Responsibilities
- Production & Laboratory Operations
- Manufacture biological indicator components in accordance with cGMP procedures, including but not limited to:
- Spore seeding and inoculation
- Agar pour plate preparation and testing
- Harvesting and washing operations
- Preparation of subassemblies and raw materials
- Execute assigned production tasks in accordance with approved manufacturing procedures and schedules
Equipment, Area, and Material Support
- Perform routine preventative maintenance and basic troubleshooting of laboratory equipment per approved SOPs
- Conduct daily area housekeeping and maintain laboratory readiness in compliance with cGMP requirements
- Perform inventory reconciliation checks and restock laboratory supplies as required
Documentation & Compliance
- Prepare, complete, and review batch records and production documentation in accordance with cGDP requirements
- Accurately maintain charts, inprocess records, and inspection aids (IAs)
- Ensure personal compliance with all Federal, State, local, and Company regulations, policies, and procedures
Operational Support & Communication
- Communicate operational issues, risks, or improvement opportunities to supervision or management
- Support test method development, validation activities, investigations, or inspections as directed
- Collaborate with crossfunctional partners including Quality, R&D, Production Planning, Manufacturing Engineering, and Master Data as required
Education and Experience Requirements
- High School Diploma or GED required.
- Bachelor's Degree in Biology, Microbiology, or a related scientific discipline preferred.
- 1-3 years of experience in a chemistry or biologics laboratory environment required.
- Experience working in an FDAregulated manufacturing environment preferred.
- Working knowledge of cGMP and cGDP requirements
- Basic laboratory techniques, including aseptic processing
- Basic computer skills (word processing and spreadsheets)
- Ability to operate automated or semiautomated laboratory equipment
- Knowledge of SAP or inventory management systems preferred
- Ability to work in a manufacturing laboratory environment
- Ability to wear required personal protective equipment (lab coat, gloves, etc.)
- Ability to lift 31-50 lbs
Schedule may include weekend work
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.
About ASP
ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.
ASP's mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP's products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.
We Are an Equal Opportunity Employer
Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.