Microbiologist

JENAVALVE TECHNOLOGY INC•Irvine, CA

1d•$90,000 - $105,000•Onsite

About The Position

The Microbiologist will serve as the technical Subject Matter Expert (SME) for the microbiology laboratory, ensuring strict compliance with ISO 14644 standards and cleanroom regulations. This role is responsible for leading complex quality investigations, own microbiological test method validations, leading biocontamination control strategies, and oversee microbiology data trending.

Requirements

Bachelor of Science in biological science discipline or equivalent with 10+ years of direct laboratory experience within cGMP regulated industry
Demonstrated experience in leading root cause analysis and managing statistical data trending programs for environmental monitoring (air/surfaces), product bioburden and critical utility systems (RODI water, compressed gases).
Strong technical writing skills
Must be able to work effectively and collaborate with cross-functional teams.
Ability to handle multiple tasks with high attention to detail and mentor team members.
Ability to adhere to personal hygiene standards
Ability to wear specialized PPE for extended periods.
Requires standing, walking and prolonged sitting
Lift and carry materials or equipment

Nice To Haves

Occasional travelling might be required to support supplier qualification

Responsibilities

Implement and maintain compliance policies for on-site controlled environments in accordance with ISO 14644 standards.
Adhere strictly to company policies regarding personnel hygiene and Controlled Environment Room (CER) cleanliness to guarantee product safety.
Act as the Subject Matter Expert (SME) for Microbiological Test Methods.
Own, execute, and improve test method validations for bioburden and new assays in compliance with applicable ISO and USP standards.
Support the internal microbiology laboratory with routine and non-routine testing, including bioburden, growth promotion, environmental monitoring (EM), and release test results.
Review contract laboratory results and perform peer reviews of internal laboratory documentation to ensure data integrity.
Assist in developing and implementing facility monitoring processes to establish and maintain robust biocontamination control strategies.
Author, review, and update Standard Operating Procedures (SOPs), validation protocols, and formal validation reports.
Monitor and analyze trends for cleanroom environmental data (air and surfaces), utilities (RODI, compressed gases), and product bioburden.
Ensure timely data review, manage alert/action limit responses, and author comprehensive trend and organism evaluation reports.
Lead complex investigations for Out-of-Specification (OOS) results, Non-Conformance Reports (NCRs), bioburden excursions, EM excursions, and contamination events.
Perform rigorous root cause analysis (RCA) to determine definitive causes and prevent recurrence.
Support Corrective and Preventive Action (CAPA) investigations by identifying systematic root causes and implementing effective corrective actions.
Coordinate the requalification activities required to maintain a compliant terminal sterilization program.
Lead or actively participate in sterilization validation projects.
Deliver technical training, mentor laboratory analysts, and oversee the formal onboarding for new team members.
Prepare the laboratory and manufacturing areas for internal and external regulatory audits.
Conduct routine quality walkthroughs and periodic process assessments to ensure strict compliance with internal work instructions.
Execute additional laboratory duties and special projects as assigned by the Laboratory Manager