Microbiology Manager

Posted 3 days 10 hours ago by Univet Limited

Permanent
Full Time
Science & Technology Jobs
Cavan, Cavan, Ireland
Job Description

We are seeking an experienced and detail-oriented Microbiology Manager to lead microbiological quality control activities within a veterinary pharmaceutical environment. The successful candidate will oversee sterility assurance programs, environmental monitoring, and microbiological testing while leading the microbiology team and ensuring full regulatory compliance.

Key Responsibilities
  • Manage and oversee all microbiological testing activities, including:
    • Sterility testing of pharmaceutical products
    • Bioburden testing of raw materials and finished products
    • Environmental monitoring of cleanrooms (air, surfaces, personnel)
    • Settle plates and active air sampling programs
  • Ensure timely and compliant execution of media preparation and growth promotion testing (GPT)
  • Review and approve microbiological data, trend reports, and laboratory results
  • Maintain and continuously improve quality documentation, including SOPs, protocols, and test records
  • Lead investigations related to out-of-specification (OOS) results and contamination events
  • Ensure compliance with GMP, EU/HPRA/FDA regulatory requirements, and internal quality standards
People Management
  • Lead, coach, and develop the microbiology team to ensure high performance and engagement
  • Allocate workload, manage resources, and ensure appropriate staffing levels
  • Conduct training, performance reviews, and competency assessments
  • Foster a culture of quality, accountability, and continuous improvement
Regulatory & Audit Responsibilities
  • Act as SME for microbiology during regulatory inspections and customer audits
  • Prepare and deliver responses to regulatory and customer audit observations
  • Lead audit readiness activities and ensure timely closure of CAPAs
  • Ensure inspection readiness of the microbiology laboratory at all times
  • Drive continuous improvement initiatives within the microbiology function
Requirements
  • Bachelor's degree (or higher) in Microbiology, Biological Sciences, or related discipline
  • 3-5 years' experience in a microbiology role within the pharmaceutical or veterinary pharmaceutical industry
  • Strong hands on experience with:
    • Sterility testing
    • Environmental monitoring (including settle plates)
    • Bioburden testing
    • Media preparation and growth promotion testing
  • Solid understanding of GMP and regulatory guidelines
  • Experience in quality documentation and data review
  • Proven people management or supervisory experience
  • Strong IT skills, including experience with laboratory systems (e.g., LIMS), data trending, and electronic quality systems
  • Demonstrated knowledge and experience in responding to regulatory and customer audits
  • Strong analytical, organisational, and communication skills
  • Experience in sterile manufacturing environments
  • Knowledge of contamination control strategies
  • Experience with audit management systems or digital quality platforms
What We Offer
  • Competitive salary and benefits package
  • Opportunity to work in a growing veterinary pharmaceutical company
  • Supportive and collaborative team environment
  • Career development and progression opportunities