Sterility Assurance Lead: Contamination Control

Allergan; Cork; On-site; EUR 90,000 - 115,000; Full time

Job summary

AbbVie Cork seeks a Sterility Assurance Lead to drive the design, qualification and operational compliance of sterile manufacturing. You will define contamination control strategy, oversee environmental monitoring and act as SME during regulatory audits and cross-functional initiatives.

You will provide microbiological input into design, qualification, and troubleshooting, lead investigations, and promote aseptic practices across operations.

Qualifications

• Minimum 4–5 years in a quality or operational role within a regulated pharmaceutical or biopharmaceutical GMP environment.
• Leadership, stakeholder influencing, and supervisory experience.
• Strong knowledge of cleanroom design and qualification, aseptic processing and microbiological operations.
• Detail-oriented, proactive with risk-based decision making and problem solving.
• Fluent English language skills and integrity in collaboration.

Responsibilities

• Own and lead the site Contamination Control Strategy in line with GMP and regulatory expectations.
• Govern clean utilities and Environmental Monitoring programmes across classified areas and support systems.
• Establish and review EM strategies, sampling plans, limits and monitoring frequencies.
• Analyse EM trends to identify contamination risks and opportunities for improvement.
• Provide microbiological input for investigations, deviations, CAPAs, and product impact assessments.
• Develop gowning, cleaning, sanitisation, and air visualisation strategies.
• Drive sterility assurance across manufacturing operations and promote aseptic practices.

Skills

Leadership/Stakeholder influence

Supervisory experience

Risk-based decision making

Communication

Collaboration

Education

Degree in Microbiology

Job description

AbbVie Cork seeks a Sterility Assurance Lead to drive the design, qualification and operational compliance of sterile manufacturing. You will define contamination control strategy, oversee environmental monitoring and act as SME during regulatory audits and cross-functional initiatives.

You will provide microbiological input into design, qualification, and troubleshooting, lead investigations, and promote aseptic practices across operations.