Senior Biological Technician (Wednesday - Sunday)

Fortive•Irvine, CA

7h•Onsite

About The Position

This role involves advanced production and laboratory operations, focusing on manufacturing biological indicator components in accordance with cGMP procedures. Responsibilities include spore seeding, inoculation, agar pour plate preparation and testing, preparation of sub-assemblies and raw materials, and harvesting/washing activities. The position also requires performing in-process and release testing, such as percent spore determination, purity testing, and titer testing. Additionally, the role entails equipment, area, and process ownership, including preventative maintenance, basic troubleshooting, ensuring housekeeping and GMP readiness, managing routine laboratory processes, and conducting inventory management. Documentation, compliance, and investigations are key, involving the preparation and review of batch records and production documentation, supporting investigations and deviations, and ensuring compliance with regulations. The role also includes technical leadership and training, mentoring junior technicians, participating in process improvement initiatives, and communicating operational issues. Safety, communication, and general responsibilities are also part of the role, supporting a strong safety culture and performing other duties as assigned.

Requirements

6+ years of relevant laboratory or biologics manufacturing experience, or 2+ years of experience with a Bachelor’s degree in a related scientific discipline.
High School Diploma or GED required.
Strong working knowledge of cGMP and cGDP requirements.
Advanced laboratory skills in aseptic processing and biologics manufacturing.
Experience working in an FDA-regulated manufacturing environment.
Proficiency with SAP or similar inventory management systems.
Basic computer skills (word processing and spreadsheets).
Ability to lift 31–50 lbs.
Ability to wear required PPE.
Ability to work in a manufacturing laboratory environment.

Nice To Haves

Bachelor’s Degree in Biology, Microbiology, or a related scientific discipline preferred.
Yellow Belt certification preferred.
Domestic travel may be required.

Responsibilities

Manufacture biological indicator components in accordance with cGMP procedures, including spore seeding and inoculation; agar pour plate preparation and testing; preparation of sub-assemblies and raw materials; harvesting and washing activities.
Perform in-process and release testing, including percent spore determination, purity testing, and titer testing.
Perform and oversee preventative maintenance and basic troubleshooting of laboratory equipment in accordance with approved SOPs.
Ensure daily area housekeeping and sustained GMP readiness.
Manage routine laboratory processes and ensure required checks and verifications are completed accurately and on time.
Conduct inventory reconciliation, material restocking, and SAP transactions as required.
Prepare, review, and verify batch records and production documentation in accordance with cGDP requirements.
Support investigations, deviations, inspections, and root cause analysis activities as directed.
Ensure personal and team compliance with all Federal, State, local, and Company regulations, policies, and procedures.
Train and mentor junior-level technicians in accordance with approved manufacturing procedures and standard work.
Participate in and actively support process improvement initiatives, including Kaizen, 5S, and efficiency projects.
Communicate operational risks, issues, and improvement opportunities to supervision and management.
Support a strong safety culture and ensure proper use of PPE and safe laboratory practices.
For individuals with informal or formal leadership responsibilities, ensure work is performed in compliance with Health, Safety, and Environmental requirements.
Perform other duties as assigned to support business needs.