Sr. Environmental Monitoring Technician

Avid Bioservices•Tustin, CA

9d•$25 - $34

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Sr. Environmental Monitoring Technician performs environmental monitoring and routine microbiological testing within a GMP biopharmaceutical manufacturing organization.

Requirements

5+ years of biotech industry experience within a GMP biopharmaceutical manufacturing organization. 2+ years of industry experience working with mammalian cell culture.
Ability to apply knowledge of good manufacturing practices and good laboratory practices daily.
The understanding and ability to perform aseptic and relevant microbiological techniques such as microbial isolation, streak plate and gram staining.
Ability to follow gowning practices for cleanroom environments.
Ability to exercise judgment within defined procedures and practices to determine appropriate action.

Nice To Haves

Bachelor’s degree (B.A.) or equivalent from four-year college or university, preferably in Microbiology or a relevant life sciences discipline.
2+ years of related experience and/or training; or equivalent combination of education and experience.
2+ years of industry experience working with mammalian cell culture.

Responsibilities

Perform environmental monitoring such as non-viable particulates, air viables, surface, temperatures in cleanroom environments within the Manufacturing area per SOP.
Perform environmental monitoring for aseptic filling processes according to SOP.
Operate monitoring equipment that includes but is not limited to Laser Particle Counter, Viable Air Sampler, Microscope, MilliFlex OasisTest System, Conductivity meter, pH meter and TOC analyzer.
Monitor temperatures of Microbiological QC equipment, such as refrigerators, freezers, and cryo-freezers.
Read EM (Environmental Monitoring) data and document results on relevant forms and electronic systems
Perform trending and generate trending charts for EM data.
Perform Cleaning Verification of cleaned production equipment.
Perform membrane filtration bioburden testing using the Milliflex system.
Perform growth promotion testing.
Coordinate sample shipment for various outside testing requirements.
Maintain inventory of department supplies and place purchase orders.
Perform visual inspection of incoming department supplies in accordance with appropriate material specifications.
Perform bioburden testing of samples per USP, EP, and JP requirements.
Responsible for EM out-of-limit results, such as notification, investigation assistance, re-testing of alert and action OOL’s, etc.
Comply with all safety policies, practices, and procedures.
Report all unsafe activities to supervisor and/or Human Resources.
Participate in proactive team efforts to achieve departmental and company goals.
Perform other duties as assigned.