Senior Microbiology Team Leader

A Senior Microbiology Team Leader is required by CareerWise Recruitment for our County Galway based client. The Senior Microbiology Team Lead is responsible for leading and coordinating microbiology laboratory operations, with primary focus on microbiological investigations, microbial method validation/verification, qualification of new laboratory equipment, contamination control, and support of sterile manufacturing operations. The role ensures all microbiological activities are performed in compliance with current GMP, GLP, regulatory expectations, and company quality standards while driving continuous improvement, technical excellence, and operational efficiency within the microbiology function.THE ROLELead microbiology investigations including environmental monitoring, sterility failures, bioburden, endotoxin, and contamination eventsDrive root cause analysis, risk assessments, CAPAs, and effectiveness checks for microbiological deviations and quality issuesEnsure compliance with GMP, GLP, Data Integrity, and regulatory standards across all laboratory activitiesOversee validation and lifecycle management of microbiological methods, equipment qualification (IQ/OQ/PQ), and method transfersReview and approve microbiology documentation, including test results, environmental monitoring data, and investigation reportsSupport and continuously improve the Environmental Monitoring (EM) program for manufacturing and aseptic areasLead and maintain microbiology quality systems, including SOPs, change controls, deviations, and trend reportingProvide technical leadership, mentoring, and training to microbiology team membersManage laboratory operations, including resource planning and prioritisation, to meet business needsSupport audits and inspections, representing the microbiology function and ensuring timely follow-up actionsDrive continuous improvement initiatives and operational excellence within the laboratoryAct as deputy to the Microbiology Laboratory Manager when requiredREQUIREMENTDegree in Microbiology, Biological Sciences, Biotechnology, or related scientific disciplineSignificant experience within a GMP microbiology laboratory environment, preferably supporting sterile manufacturing, biologics, or aseptic processing operationsExperience in a supervisory, team lead, or people management role within a regulated environmentSignificant experience within a GMP pharmaceutical, sterile manufacturing, biologics, or medical device microbiology laboratoryStrong experience in microbiological investigations, contamination control, environmental monitoring, and aseptic processing supportExperience in microbial method validation/verification and laboratory equipment qualificationStrong knowledge of EU GMP Annex 1, FDA Guidance for Aseptic Processing, USP/EP microbiological requirements, and Data Integrity expectationsExperience leading teams and coordinating laboratory operations in a regulated environmentKnowledge of Annex I and US and EMA GMP regulationsHave working knowledge of isolator technologyHave working knowledge of MODAExperience with sterile injectable products, aseptic manufacturing processes and contamination control strategies