QC Microbiology Team Lead

RECRUITERS; Cork; On-site; EUR 90,000 - 130,000; Full time

Job summary

RECRUITERS in Cork, Ireland seeks an experienced QC Microbiology Lead to head the QC Microbiology laboratory at a biopharmaceutical site. You will provide technical and people leadership, ensuring testing, environmental monitoring and contamination control align with cGMP and production schedules.

Reporting to the Head of QC, you will drive lean initiatives, oversee audits, and collaborate across QA, Manufacturing, Facilities and Regulatory Affairs to maintain an inspection-ready lab and

Qualifications

• Experience in pharmaceutical/biopharmaceutical microbiology with people management.
• Knowledge of cGMP, FDA and EU regulatory requirements.
• Experience in environmental monitoring, sterility testing and microbiological investigations.
• Strong communication and planning skills; Lean Laboratory/continuous improvement is an advantage.

Responsibilities

• Lead and develop the QC Microbiology team, ensuring compliant and timely testing.
• Own Environmental Monitoring and Utilities Monitoring programmes, including water and compressed gases.
• Oversee OOS, OOT and microbiological excursion investigations, root cause analysis and CAPAs.
• Own Sterility Testing Programme supporting Drug Product operations.
• Manage external microbiology laboratories, contractors and suppliers.
• Support method and equipment validation, equipment lifecycle activities and new equipment introduction.
• Drive Lean Laboratory, 5S and continuous improvement initiatives.
• Plan laboratory resources and capacity in line with manufacturing requirements.
• Maintain an inspection-ready laboratory and represent QC Microbiology during regulatory and customer audits.
• Author, review and approve relevant SOPs, protocols, reports and change controls.
• Collaborate with QA, Manufacturing, Facilities, Regulatory Affairs and Supply Chain.
• Support recruitment, training, performance management, budgeting and team development.

Skills

People leadership

Microbiology

cGMP compliance

Regulatory knowledge

Environmental monitoring

Job description

We are seeking an experienced QC Microbiology Lead to lead the QC Microbiology laboratory team at a biopharmaceutical manufacturing site in Cork.

Reporting to the Head of QC, you will provide both technical and people leadership, ensuring microbiological testing, environmental monitoring and contamination control activities are delivered in compliance with cGMP requirements and manufacturing schedules.

Key Responsibilities

• Lead and develop the QC Microbiology team, ensuring compliant and timely testing.
• Own the site's Environmental Monitoring and Utilities Monitoring programmes, including water and compressed gases.
• Oversee OOS, OOT and microbiological excursion investigations, root cause analysis and CAPAs.
• Own and oversee the Sterility Testing Programme supporting Drug Product operations.
• Manage external microbiology laboratories, contractors and suppliers.
• Support method and equipment validation, equipment lifecycle activities and new equipment introduction.
• Drive Lean Laboratory, 5S and continuous improvement initiatives.
• Plan laboratory resources and capacity in line with manufacturing requirements.
• Maintain an inspection-ready laboratory and represent QC Microbiology during regulatory and customer audits.
• Author, review and approve relevant SOPs, protocols, reports and change controls.
• Collaborate with QA, Manufacturing, Facilities, Regulatory Affairs and Supply Chain.
• Support recruitment, training, performance management, budgeting and team development.

Experience & Skills

• Strong experience in pharmaceutical/biopharmaceutical microbiology and aseptic operations, with previous people management and team leadership experience.
• Good knowledge of cGMP, FDA and EU regulatory requirements, along with experience in environmental monitoring, sterility testing and microbiological investigations.
• Strong communication, organisational and planning skills are essential, while Lean Laboratory / continuous improvement experience is an advantage.

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