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Scientist (Sunday Wednesday)
Job Location:
Job Location:
Irvine, CA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
12 June 2026 (30+ days ago)
Posted:
Application Deadline:
9 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Description
Production & Laboratory Operations
-Culture and test bacterial spores used in the biological indicator manufacturing process in accordance with cGMPs and approved SOPs
-Execute advanced production activities including:
- Spore inoculation and propagation;
- Agar pour plate preparation and testing;
- Sampling testing and data generation
-Prepare review and verify batch records and production documentation in accordance with cGDP requirements
-Provide technical support for both new and existing products during routine manufacturing and scaleup activities
Troubleshooting Investigations & Technical Support
-Investigate and troubleshoot product deviations process excursions and production issues using appropriate scientific and technical diagnostic methods
-Support problem investigations inspections and root cause analyses as directed
-Apply standard scientific principles theories and concepts to evaluate data identify root causes and recommend corrective actions
-Exercise judgment within established practices and procedures when selecting methods and techniques to resolve technical issues
Process Development & Improvement
-Contribute to the origination design and execution of experiments including:
- Development of methodologies;
- Review analysis and interpretation of data;
- Preparation of technical summaries and reports
-Support test method development validation and optimization activities
-Participate in process improvement initiatives including Kaizen 5S and efficiency projects
Systems & Area Ownership
-Own and manage assigned laboratory or operational systems including:
- PMs and calibrations oversight;
- Inventory management and SAP transactions;
- Change Orders (COs) Nonconformances (NCs) Laboratory Investigations (LIs) and CAPAs
-Coordinate activities across crossfunctional teams including Quality R&D Production Planning and Manufacturing Engineering
-Maintain clear and complete technical documentation for projects and assigned systems
Training Leadership & Communication
-Train coach and certify juniorlevel employees on manufacturing procedures test methods and standard work
-Coordinate and manage independent projects under the guidance of process leaders and project facilitators
-Communicate technical risks business issues and improvement opportunities to management
-For individuals with supervisory responsibilities ensure adherence to Health Safety and Environmental requirements
Education and Experience Requirements
24 years of relevant experience in a regulated laboratory or manufacturing environment; or
03 years of experience with a Masters degree; or
High School Diploma or equivalent with 8 years of relevant industry experience.
Bachelors Degree in Biology Microbiology or a related scientific discipline preferred
Required Knowledge & Skills
-Strong knowledge of cGMP and cGDP requirements
-Experience working in an FDAregulated environment
-Laboratory experience in aseptic techniques and biologics manufacturing
-Ability to summarize interpret and report scientific data
-Proficiency with spreadsheet and database applications
-Effective written and verbal communication skills
-Ability to work collaboratively in crossfunctional teams
Preferred qualifications
- Experience with SAP inventory or laboratory systems
- Experience with statistical tools (e.g. Minitab)
- Yellow Belt or Green Belt certification
- TraintheTrainer or Training Within Industry (TWI) experience
Work Environment & Physical Requirements
- Schedule may include weekend work
- Domestic travel may be required (010%)
- Ability to lift 3150 lbs
- Ability to wear required PPE
- Ability to work in a manufacturing laboratory environment
Required Experience:
IC
About Company
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 d ... View more
