Sterility Assurance Lead

Bring your expertise in aseptic manufacturing and sterility assurance to a role where your knowledge drives compliance, quality, and continuous improvement.

R&D Partners is seeking a Sterility Assurance Lead to join a pharmaceutical company in Ireland. This role focuses on overseeing and developing sterility assurance activities and contamination control strategies to ensure compliance with cGMP standards. The ideal candidate will have strong expertise in sterility assurance, aseptic manufacturing, and microbiology, with a proven ability to lead investigations and contribute to personnel training and development.

Please note that to be considered for this role you must have the right to work in this location.

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.

Key Skills and Requirements:

Education: Honours degree in Microbiology; Postgraduate studies preferred.

Experience:

• 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.

Skills:

• Leadership in sterility assurance investigations.
• Ability to train and mentor teams on sterility assurance topics.
• Familiarity with new technologies related to sterility assurance.

Compensation: – only to be included for the above highlighted US locations!

For more information, please contact Mandi Cakwe

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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