Senior Microbiology Team Lead - Bewerbung
Location: Inverin, County Galway, Ireland
Time type: Vollzeit
Posted on: Heute ausgeschrieben
Job requisition id: RMylan Teoranta
The Role & What You Will Be Doing
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.
About Your Skills & Experience
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.
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 Annex1, 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 AnnexI and US and EMA GMP regulations.
Working knowledge of isolator technology.
Working knowledge of MODA.
Experience with sterile injectable products, aseptic manufacturing processes, and contamination control strategies.
Benefits at Viatris
Competitive salary and bonus scheme.
Health insurance and pension.
Work-life balance initiatives.
Excellent career progression opportunities.
Diversity & inclusion commitment.
#J-*****-Ljbffr