Sterility Assurance Lead: Aseptic Quality & Compliance

R&D Partners; Waterford; On-site; EUR 90,000 - 120,000; Full time

Job summary

R&D Partners is recruiting a Sterility Assurance Lead to join a pharmaceutical company in Ireland. You will oversee sterility assurance activities, contamination control strategies, and training programs to ensure compliance with cGMP and regulatory expectations.

The role emphasizes leading investigations, advancing contamination control, and supporting process validation and audits. A degree in Microbiology and strong leadership are essential for success.

Qualifications

• Strong background in sterility assurance, contamination control, and aseptic manufacturing.
• Expertise in environmental monitoring, media fill programs, cleaning validation, and microbiology.
• Experience with sterility investigations, process validation, and risk assessment.
• Knowledge of cGMP compliance and audit/inspection readiness.

Responsibilities

• Develop and implement sterility assurance and contamination control strategies.
• Oversee sterility assurance programs, including: Contamination control, Media fill programs, Environmental monitoring and performance qualification.
• Decontamination, sterilization, and depyrogenation processes.
• Cleaning validation for microbial properties (bioburden and endotoxin).
• Manage and prevent sterility breaches, such as leaks or glove damage.
• Lead major sterility assurance investigations and provide support for significant projects or contamination concerns.
• Review documents related to commissioning, qualification, process validation, risk assessment, and regulatory sterility assurance aspects.
• Benchmark industry best practices through networking and attending key events.
• Provide quarterly and annual sterility assurance updates.
• Contribute to personnel qualification programs, training, and mentoring on sterility assurance topics.
• Participate in audits, inspections, and visits focusing on sterility assurance aspects.

Skills

Leadership in investigations

Training & mentoring

Sterility assurance

Contamination control

Education

Honours degree in Microbiology

Postgraduate studies

Tools

Environmental monitoring

Media fill programs

Job description

R&D Partners is recruiting a Sterility Assurance Lead to join a pharmaceutical company in Ireland. You will oversee sterility assurance activities, contamination control strategies, and training programs to ensure compliance with cGMP and regulatory expectations.

The role emphasizes leading investigations, advancing contamination control, and supporting process validation and audits. A degree in Microbiology and strong leadership are essential for success.