Senior Sterility Assurance Manager – Microbiology

CareerWise Recruitment; Galway; On-site; EUR 120,000 - 150,000; Full time

Job summary

CareerWise Recruitment seeks a Senior Microbiology Manager specialising in Sterility Assurance in Galway. The role leads sterility strategies, oversight of aseptic processes, contamination control, and CAPA across multiple teams to ensure regulatory compliance and product sterility.

The ideal candidate has extensive microbiology background with hands-on sterility experience, strong regulatory knowledge, and leadership capabilities to drive quality excellence.

Qualifications

• Bachelor’s degree (or higher) in Microbiology or related field.
• Extensive experience in Sterility Assurance and aseptic manufacturing.
• Proven contamination control strategies and validation experience.
• Experience with regulatory audits and GMP regulations.

Responsibilities

• Lead site Sterility Assurance strategy and program across operations.
• Develop and maintain Contamination Control Strategy for sterile manufacturing.
• Conduct risk assessments for aseptic processes and environmental monitoring.
• Oversee environmental monitoring program and investigations with CAPA.
• Coordinate aseptic process simulations and review related documentation.
• Support validation activities for sterility testing and laboratory systems.
• Represent sterility assurance in audits and regulatory inspections.
• Collaborate cross-functionally with Quality, Manufacturing, Engineering, and Microbiology teams.

Skills

Sterility Assurance

Aseptic Manufacturing

Environmental Monitoring

Regulatory Knowledge

Risk Assessment

Team Leadership

Contamination Control

Root Cause Analysis

Documentation & QC

Communication

Education

Bachelor’s Degree in Microbiology

Tools

MODA

Excel

Project Management Software

Job description

CareerWise Recruitment seeks a Senior Microbiology Manager specialising in Sterility Assurance in Galway. The role leads sterility strategies, oversight of aseptic processes, contamination control, and CAPA across multiple teams to ensure regulatory compliance and product sterility.

The ideal candidate has extensive microbiology background with hands-on sterility experience, strong regulatory knowledge, and leadership capabilities to drive quality excellence.