Sterility Assurance Lead - Biologics

AbbVie Inc.; Central City (CO); Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

AbbVie is seeking a Sterility Assurance Lead to design, qualify, and ensure sterile manufacturing compliance at AbbVie Cork. You will own the contamination control strategy, govern EM programs, and provide microbiological expertise for investigations and CAPAs.

The role requires leadership and collaboration across operations, QC microbiology, and facilities teams. Ideal candidates hold a degree in microbiology or related fields with 4–5 years in regulated pharma, aseptic processing, and strong

Qualifikationen

• Degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or related discipline.
• 4–5 years’ experience in a quality or operational role within a regulated GMP environment, including aseptic experience.
• Demonstrated leadership, stakeholder influencing, and supervisory experience with processes and procedures.

Aufgaben

• Own and lead the site Contamination Control Strategy in line with GMP regulations.
• Govern EM programmes across classified areas, utilities, 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, APS, and air visualisation strategies.
• Drive operational sterility assurance across manufacturing operations.
• Promote aseptic practices through training and collaboration with Operations and QC Microbiology.
• Provide microbiological input into facility design, zoning, and cleanroom classification.
• Act as the sterility assurance SME for audits, regulatory inspections, and cross-functional initiatives.

Kenntnisse

Leadership

Stakeholder influencing

Supervisory experience

Communication

Problem solving

Attention to detail

Ausbildung

Bachelors in Microbiology/Biological/Pharmaceutical Sciences

Jobbeschreibung

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

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.

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.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.