Sterility Assurance Lead - Aseptic Manufacturing Leader

AbbVie; Cork; On-site; EUR 70,000 - 110,000; Full time

Job summary

AbbVie Cork is seeking a Sterility Assurance Lead to design, qualify, and ensure compliance of sterile manufacturing. You will define contamination control strategy, oversee EM programs, and provide microbiological expertise for investigations and regulatory audits.

The role requires leadership, GMP knowledge, and a strong background in aseptic processing, cleanrooms, and contamination control, with fluent English and stakeholder collaboration across Operations and QC Microbiology.

Qualifications

• Degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or a related discipline.
• 4–5 years’ experience in a quality or operational role within a regulated pharmaceutical or biopharmaceutical GMP environment, including laboratory and aseptic sterile fill-finish experience.
• Demonstrated leadership, stakeholder influencing, and supervisory experience, with the ability to build effective systems, procedures, and ways of working.
• Strong knowledge of cleanroom design and qualification, aseptic processing, microbiological laboratory operations, contamination control strategies, and applicable regulations.
• Detail-oriented, proactive, and results-driven, with strong risk-based decision‑making, problem‑solving, communication, collaboration, integrity, and fluent English language skills.

Responsibilities

• Own and lead the site Contamination Control Strategy in line with GMP, regulatory expectations, and industry best practice.
• Govern clean utilities and Environmental Monitoring (EM) programmes across classified areas, utilities, and support systems.
• Establish and periodically review EM strategies, sampling plans, limits, and monitoring frequencies.
• Analyse EM trends to identify contamination risks, adverse trends, and opportunities for improvement.
• Provide microbiological expertise for investigations, deviations, contamination events, root cause analysis, CAPAs, and product impact assessments.
• Develop and oversee gowning, cleaning, sanitisation, APS, and air visualisation strategies.
• Drive operational sterility assurance and support contamination control measures across manufacturing operations.
• Promote strong aseptic practices through training, cleanroom presence, and collaboration with Operations and QC Microbiology.
• Provide microbiological input into facility design, zoning, cleanroom classification, personnel/material flows, utilities, and qualification activities.
• Act as the sterility assurance SME for audits, regulatory inspections, governance forums, and cross-functional initiatives.

Skills

Leadership

Microbiology

GMP

Contamination control

Regulatory compliance

Education

BSc Microbiology

Job description

AbbVie Cork is seeking a Sterility Assurance Lead to design, qualify, and ensure compliance of sterile manufacturing. You will define contamination control strategy, oversee EM programs, and provide microbiological expertise for investigations and regulatory audits.

The role requires leadership, GMP knowledge, and a strong background in aseptic processing, cleanrooms, and contamination control, with fluent English and stakeholder collaboration across Operations and QC Microbiology.