Senior Microbiologist: Cleanroom Compliance & Validation

Jenavalve Technology Inc; Irvine (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Jenavalve Technology Inc. in Irvine, CA, seeks a Microbiologist to serve as SME for the microbiology lab, ensuring ISO 14644 and cleanroom compliance. You will lead complex quality investigations, own test method validations, and oversee biocontamination control strategies.

Responsibilities include environmental monitoring, trend analysis, RCA for OOS/NCRs, CAPA support, SOP authoring, and audit readiness. Candidate should have a BS in biological sciences and 10+ years in cGMP labs.

Qualifications

• Bachelor of Science in biological sciences or equivalent with 10+ years in a cGMP laboratory.
• Proven ability to lead root cause analysis and data trending programs for environmental monitoring and bioburden.

Responsibilities

• Lead SME for microbiology test methods and validations (bioburden and new assays).
• Ensure ISO 14644 compliance and CER cleanliness for controlled environments.
• Support biocontamination control strategies and data trending reviews.

Skills

Technical writing

Cross-functional collaboration

Detail orientation

Mentoring

Education

B.S. in Biological Sciences

Job description

Jenavalve Technology Inc. in Irvine, CA, seeks a Microbiologist to serve as SME for the microbiology lab, ensuring ISO 14644 and cleanroom compliance. You will lead complex quality investigations, own test method validations, and oversee biocontamination control strategies.

Responsibilities include environmental monitoring, trend analysis, RCA for OOS/NCRs, CAPA support, SOP authoring, and audit readiness. Candidate should have a BS in biological sciences and 10+ years in cGMP labs.