Role overviewSenior microbiologist who defines and strengthens the contamination control strategy for non-sterile solid-dose manufacturing and packaging, and supports microbiology lab readiness and investigations.Key responsibilitiesDevelop or remediate the site Contamination Control Strategy (CCS)Review and improve the environmental monitoring program, sampling plans, limits and trendingDefine objectionable-organism assessments for non-sterile productsAssess water system monitoring and disinfectant efficacy studiesPrepare the microbiology lab for inspection; lead or review microbiological investigationsTrain site personnel on contamination control and aseptic-behavior basics relevant to non-sterile operationsMandatory requirements10+ years in pharmaceutical microbiology, environmental monitoring and contamination controlExperience writing or remediating a contamination control strategyExperience with microbiological investigations and EM excursionsKnowledge of USP , , , and water system requirementsPlus the common requirements listed on page 1.Preferred qualificationsNon-sterile solid oral dosage experienceMicrobiology lab management or QC Micro lead backgroundExperience presenting micro topics during Health Canada/FDA inspections
