Microbiology Manager, Cootehill

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

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