Biological Technician

Fortive•Irvine, CA

2d•Onsite

About The Position

This role is responsible for manufacturing biological indicator components in accordance with cGMP procedures. Key responsibilities include spore seeding, inoculation, agar pour plate preparation and testing, harvesting, washing operations, and preparation of sub-assemblies and raw materials. The technician will execute assigned production tasks according to approved manufacturing procedures and schedules. Additionally, the role involves performing routine preventative maintenance and basic troubleshooting of laboratory equipment, conducting daily housekeeping, maintaining laboratory readiness, and restocking supplies. Accurate documentation of batch records and production activities in compliance with cGDP is essential. The position also requires supporting test method development, validation activities, investigations, and collaborating with cross-functional teams. The schedule may include weekend work.

Requirements

High School Diploma or GED required.
1–3 years of experience in a chemistry or biologics laboratory environment required.
Basic laboratory techniques, including aseptic processing.
Basic computer skills (word processing and spreadsheets).
Ability to operate automated or semi-automated laboratory equipment.
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.

Nice To Haves

Bachelor’s Degree in Biology, Microbiology, or a related scientific discipline preferred.
Experience working in an FDA-regulated manufacturing environment preferred.
Working knowledge of cGMP and cGDP requirements.
Knowledge of SAP or inventory management systems preferred.

Responsibilities

Manufacture biological indicator components in accordance with cGMP procedures, including spore seeding and inoculation, agar pour plate preparation and testing, harvesting and washing operations, and preparation of sub-assemblies and raw materials.
Execute assigned production tasks in accordance with approved manufacturing procedures and schedules.
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.
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.
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.