The Sterility Assurance Lead will play a critical role in the design, qualification, and operational compliance of sterile manufacturing at AbbVie Cork. This role will be pivotal in ensuring all products manufactured meet the standards required for marketed drug products. They will be accountable for defining contamination control strategy and its sterility assurance practices and sever as a subject matter expert on sterility assurance in regulatory audits and cross-functional initiatives.
Responsibilities include:
- 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.