Sterility Assurance Lead - GMP Contamination Control

AbbVie Inc.; Colorado Springs (CO); Sur place; USD 84 000 - 118 000; Plein temps

Résumé du poste

AbbVie Inc. is recruiting a Sterility Assurance Lead to oversee sterile manufacturing compliance at the Cork site.

You will define contamination control strategies, supervise EM programmes, and provide microbiological expertise for investigations, CAPAs and regulatory interactions. The role requires a degree in microbiology or related field, 4–5 years in a GMP pharma environment, and strong leadership with excellent communication in English.

Qualifications

• Degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or a related discipline.
• Demonstrated leadership, stakeholder influencing, and supervisory experience in a regulated environment.
• Fluent English language skills and strong communication abilities.

Responsabilités

• Own and lead the site Contamination Control Strategy in line with GMP and regulatory expectations.
• Govern EM programmes across classified areas and support systems.
• Establish and review EM strategies, sampling plans, limits and monitoring frequencies.
• Provide microbiological expertise for investigations, CAPAs and product impact assessments.
• Develop gowning, cleaning, and aseptic processing strategies and contribute to facility design input.
• Act as sterility assurance SME for audits and regulatory inspections.

Connaissances

Leadership

Stakeholder management

Supervisory experience

Formation

Microbiology/Biological Sciences/Pharmaceutical Sciences degree

Description du poste

AbbVie Inc. is recruiting a Sterility Assurance Lead to oversee sterile manufacturing compliance at the Cork site.

You will define contamination control strategies, supervise EM programmes, and provide microbiological expertise for investigations, CAPAs and regulatory interactions. The role requires a degree in microbiology or related field, 4–5 years in a GMP pharma environment, and strong leadership with excellent communication in English.