Microbiologist II

Microbiologist II | Full-Time, Permanent Costa Mesa, CA (Orange County) $70,000 – $85,000 We’re partnering with a confidential life sciences organization in the Southern California region that operates within a highly regulated GMP manufacturing environment, supporting the development and production of complex biologics and/or sterile pharmaceutical products. They are known for strong quality standards, a collaborative technical culture, and a commitment to continuous improvement across manufacturing and QC operations. Role Overview This Microbiologist II role acts as a key technical expert within an aseptic manufacturing environment, with a strong focus on environmental monitoring (EM), microbiology testing, and contamination control. The position plays a critical part in ensuring product quality, regulatory compliance, and ongoing process optimization across site operations. You’ll also take ownership of technical investigations, trending analysis, and microbiological method support while partnering closely with Quality, Manufacturing, and cross‑functional technical teams. Key Responsibilities Serve as a subject matter expert for environmental monitoring and microbiology testing in an aseptic GMP setting Support and lead microbiology‑related projects including method development, transfer, validation, and sanitization studies Perform and support bioburden and sterility testing method suitability and validation Conduct trending and analysis of EM, personnel, and utility monitoring data to support quality reviews and investigations Lead deviation investigations including root cause analysis, impact assessments, and CAPA implementation Author and review technical protocols, validation reports, and EM trend reports for aseptic operations Evaluate process changes for potential microbiological impact and compliance risk Support audits (internal, client, regulatory, and vendor) as a microbiology SME What We’re Looking For Bachelor’s degree in Microbiology, Biology, Biochemistry, or related field 3+ years of experience in biotech or pharmaceutical QC/manufacturing environment Strong background in microbiology and environmental monitoring in GMP settings Experience with method development, validation, and aseptic testing preferred Strong communication skills and ability to collaborate across functions #J-18808-Ljbffr