Scientist (Sunday - Wednesday)

Fortive•Irvine, CA

2d•Onsite

About The Position

The Scientist will be responsible for culturing and testing bacterial spores used in the biological indicator manufacturing process in accordance with cGMPs and approved SOPs. This role involves executing advanced production activities, preparing and reviewing batch records, and providing technical support for products during manufacturing and scale-up. The Scientist will also investigate and troubleshoot product deviations and process excursions, contribute to experiment design and execution for process development, and manage assigned laboratory or operational systems. Additionally, the role includes training junior employees, managing projects, and communicating technical information to management.

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

Bachelor’s Degree in Biology, Microbiology, or a related scientific discipline preferred
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

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