Microbiology and Sterility Assurance Lead (Compounding)

Location: Dublin, Ireland; onsite, full-time

Company

hirify.global is a global healthcare company developing and delivering medical products and therapies for hospitals, clinics, and home care.

What you will do

• Deploy and maintain sterility assurance, environmental control, and environmental monitoring programs for Dublin compounding facilities in line with current GMP and global strategy.
• Support standardization across the global compounding organization and implement new microbiological testing and environmental control technologies.
• Lead investigations into product and process deviations, customer complaints, nonconformances, and quality incidents as a technical approver.
• Interpret microbial identification and environmental monitoring data, establish alert limits, and track and report quality metrics.
• Conduct validation and experimental design for microbiological methods and sanitization processes, including oversight of external laboratories.
• Develop quality documentation and deliver microbiological and aseptic operator training to operational and quality staff.

Requirements

• Degree in Microbiology or relevant equivalent experience.
• At least 3 years of experience implementing environmental control programs and investigating and correcting out-of-limit results; 5 years of microbiology experience in an aseptic facility is preferred.
• Strong operational experience in an aseptic manufacturing environment and practical aseptic technique experience.
• Experience with FMEA, DMAIC, process mapping, data interpretation, Lean manufacturing, and critical equipment and process change control.
• Experience validating microbiological methods or sanitization processes, with strong communication, collaboration, decision-making, and problem-solving skills.
• Ability to work autonomously, take initiative, manage ambiguity, and maintain a strong quality and patient focus.

Culture & Benefits

• Work with an experienced and diverse team supporting hirify.global’s Clinical Nutrition business and patients with chronic and oncology conditions.
• Independent role with the opportunity to develop strategy and make a direct operational impact.
• Exposure to medical devices and pharmaceutical operations.
• Internal training tailored to business needs and career goals.
• Stable employment with an established global healthcare company.