Biological Technician (Wednesday – Saturday)

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 sub‑assemblies 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, in‑process 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 cross‑functional 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 FDA‑regulated 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 semi‑automated 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