Sterility Assurance Lead - Biologics

📋 Description

• The Sterility Assurance Lead drives contamination control and sterility practices at AbbVie Cork.
• Own and lead site Contamination Control Strategy (GMP/regulatory expectations).
• Oversee Environmental Monitoring programs across classified areas and support systems.
• Analyse EM trends to identify risks and improvement opportunities.
• Provide microbiological input for investigations, CAPAs, and product impact assessments.
• Develop gowning, cleaning, sanitisation, APS, and air visualisation strategies.

🎯 Requirements

• Degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or related discipline.
• 4–5 years in quality or operational role in regulated pharma/biopharma GMP environment, incl.
• Demonstrated leadership, stakeholder influence, and supervisory experience.
• Strong knowledge of cleanroom design, aseptic processing, and contamination control.
• Detail-oriented, proactive, and fluent in English with strong communication.

🎁 Benefits

• AbbVie equal opportunity employer information available in official postings.
• Company information and social links provided in the original posting.