Scientist (Sunday - Wednesday)

Fortive•Irvine, CA

7h•Onsite

About The Position

The Scientist role is responsible for executing advanced production activities, including spore inoculation and propagation, agar pour plate preparation and testing, and sampling, testing, and data generation. This role also involves preparing, reviewing, and verifying batch records and production documentation in accordance with cGDP requirements. Additionally, the Scientist will provide technical support for new and existing products during routine manufacturing and scale-up activities. The position requires investigating and troubleshooting product deviations, process excursions, and production issues using scientific and technical diagnostic methods, supporting problem investigations, and applying scientific principles to evaluate data and recommend corrective actions. The Scientist will also contribute to process development and improvement by designing and executing experiments, developing methodologies, analyzing data, and preparing technical summaries. This includes supporting test method development, validation, and optimization, and participating in process improvement initiatives. The role involves owning and managing assigned laboratory or operational systems, including PMs, calibrations, inventory management, SAP transactions, Change Orders, Nonconformances, Laboratory Investigations, and CAPAs. The Scientist will coordinate activities across cross-functional teams and maintain clear technical documentation. Furthermore, the Scientist will train and coach junior employees, coordinate independent projects, and communicate technical risks and opportunities to management. For individuals with supervisory responsibilities, ensuring adherence to Health, Safety, and Environmental requirements is also part of the role.

Requirements

2–4 years of relevant experience in a regulated laboratory or manufacturing environment; or 0–3 years of experience with a Master’s degree; or High School Diploma or equivalent with 8+ years of relevant industry experience.
Strong knowledge of cGMP and cGDP requirements
Experience working in an FDA-regulated 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 cross-functional teams

Nice To Haves

Experience with SAP inventory or laboratory systems
Experience with statistical tools (e.g., Minitab)
Yellow Belt or Green Belt certification
Train-the-Trainer or Training Within Industry (TWI) experience
Bachelor’s Degree in Biology, Microbiology, or a related scientific discipline preferred

Responsibilities

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 scale-up activities
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
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
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 cross-functional teams including Quality, R&D, Production Planning, and Manufacturing Engineering
Maintain clear and complete technical documentation for projects and assigned systems
Train, coach, and certify junior-level 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