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Jobtailor is seeking an experienced microbiology professional to perform environmental monitoring, microbial analyses, and utility testing in a validated manufacturing environment.
You will support aseptic process simulations, gown qualification, and laboratory stewardship activities while contributing to quality systems and SOPs. Strong documentation and organization are essential.
• Perform routine and non-routine environmental monitoring (air and surface sampling) and utility testing (WFI, USP water, pure steam, and clean compressed air) to ensure manufacturing environments meet strict quality standards.
• Conduct complex microbiology-based analysis on raw materials, in-process samples, and final products, including endotoxin, bioburden, TOC/Conductivity, and sterility testing.
• Provide critical production support by participating in aseptic process simulations and production fills, maintaining gown qualification to operate within sterile manufacturing environments.
• Lead laboratory stewardship activities, including growth promotion of culture media, microbial identification, equipment calibration support, and maintaining meticulous inventory and safety standards.
• Support site quality systems by assisting in OOS/OOT investigations, drafting and revising SOPs, and preparing method validation protocols and analytical study reports.
Requirements
Core Competencies
Demonstrates expertise in microbiology-based analysis, aseptic techniques, and sterile gowning within regulated manufacturing environments. Proficient in environmental monitoring, quality systems support, and laboratory stewardship activities.
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