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 Role
Lead microbiology investigations including environmental monitoring, sterility failures, bioburden, endotoxin, and contamination events.
Drive root cause analysis, risk assessments, CAPAs, and effectiveness checks for microbiological deviations and quality issues.
Ensure compliance with GMP, GLP, Data Integrity, and regulatory standards across all laboratory activities.
Oversee validation and lifecycle management of microbiological methods, equipment qualification (IQ/OQ/PQ), and method transfers.
Review and approve microbiology documentation, including test results, environmental monitoring data, and investigation reports.
Support and continuously improve the Environmental Monitoring (EM) program for manufacturing and aseptic areas.
Lead and maintain microbiology quality systems, including SOPs, change controls, deviations, and trend reporting.
Provide technical leadership, mentoring, and training to microbiology team members.
Manage laboratory operations, including resource planning and prioritisation, to meet business needs.
Support audits and inspections, representing the microbiology function and ensuring timely follow-up actions.
Drive continuous improvement initiatives and operational excellence within the laboratory.
Act as deputy to the Microbiology Laboratory Manager when required.
Requirements
Degree in Microbiology, Biological Sciences, Biotechnology, or related scientific discipline.
Significant experience within a GMP microbiology laboratory environment, preferably supporting sterile manufacturing, biologics, or aseptic processing operations.
Experience in a supervisory, team lead, or people management role within a regulated environment.
Significant experience within a GMP pharmaceutical, sterile manufacturing, biologics, or medical device microbiology laboratory.
Strong experience in microbiological investigations, contamination control, environmental monitoring, and aseptic processing support.
Experience in microbial method validation/verification and laboratory equipment qualification.
Strong knowledge of EU GMP Annex 1, FDA Guidance for Aseptic Processing, USP/EP microbiological requirements, and Data Integrity expectations.
Experience leading teams and coordinating laboratory operations in a regulated environment.
Knowledge of Annex I and US and EMA GMP regulations.
Have working knowledge of isolator technology.
Have working knowledge of MODA.
Experience with sterile injectable products, aseptic manufacturing processes and contamination control strategies.
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