Lead Microbiologist: Cleanroom Compliance & Data Trending

JenaValve Technology, Inc.; Irvine (CA); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

JenaValve Technology, Inc. in Irvine, CA seeks a Microbiologist to serve as the technical SME for the microbiology laboratory, ensuring strict ISO 14644 compliance and cleanroom regulations.

This role leads complex quality investigations, owns microbiological test method validations, and oversees microbiology data trending. The role requires 10+ years of direct cGMP laboratory experience, strong technical writing skills, and the ability to mentor analysts.

Qualifikationen

• 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).

Aufgaben

• Regulatory & Cleanroom Compliance: 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.
• Test Method Ownership: 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.
• Laboratory Operations & Support: Support the internal microbiology laboratory with routine and non-routine testing, including bioburden, growth promotion, environmental monitoring (EM), and release test results.
• Data Review & Quality Assurance: Review contract laboratory results and perform peer reviews of internal laboratory documentation to ensure data integrity.
• Contamination Control: Assist in developing and implementing facility monitoring processes to establish and maintain robust biocontamination control strategies.
• Documentation & Authoring: Author, review, and update Standard Operating Procedures (SOPs), validation protocols, and formal validation reports.
• Environmental Monitoring & Trending: 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.
• Investigations & Root Cause Analysis: 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.
• CAPA Management: Support Corrective and Preventive Action (CAPA) investigations by identifying systematic root causes and implementing effective corrective actions.
• Sterilization Validation: Coordinate the requalification activities required to maintain a compliant terminal sterilization program. Lead or actively participate in sterilization validation projects.
• Training & Mentorship: Deliver technical training, mentor laboratory analysts, and oversee the formal onboarding for new team members.
• Audit Readiness: 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.
• Operational Support: Execute additional laboratory duties and special projects as assigned by the Laboratory Manager

Kenntnisse

Technical writing

Cross-functional collaboration

Mentoring

Ausbildung

Bachelor's degree in biological science

Jobbeschreibung

JenaValve Technology, Inc. in Irvine, CA seeks a Microbiologist to serve as the technical SME for the microbiology laboratory, ensuring strict ISO 14644 compliance and cleanroom regulations.

This role leads complex quality investigations, owns microbiological test method validations, and oversees microbiology data trending. The role requires 10+ years of direct cGMP laboratory experience, strong technical writing skills, and the ability to mentor analysts.