Job Description
Associate Director, Site Sterility Lead position at our facility in Dundalk. Our vaccine manufacturing facility is dedicated to formulating and filling vaccine products that improve and transform lives globally. This role offers a high‑impact opportunity to shape aseptic standards, mentor operations personnel, and influence the long‑term success of sterile product manufacturing in a dynamic, multi‑product environment.
Key Responsibilities
Drive excellence in sterile manufacturing through expert coaching, oversight of cleanroom behaviors and contamination control, and strategic continuous improvement.
Support sitewide sterility assurance initiatives, ensuring alignment with current regulatory standards including EU GMP Annex 1 (2023), Annex 15, and cGMP requirements.
Lead the design and execution of training programs, AVS, APS, personnel qualification, and contamination control strategies, collaborating with Quality, Validation, and Operations teams.
Serve as the Subject Matter Expert (SME) for site sterility assurance concerns, providing guidance to departments including QC and Manufacturing, and driving site inspection readiness and regulatory compliance.
Share expertise in microbiology and best practices to ensure compliance and operational efficiency.
Act as the site owner of the Environmental Monitoring (EM) Program and trending, participating in and leading microbial‑related investigations, including root cause analysis (RCA).
Assist in creating and updating microbiological technical documents, including Contamination Control Strategies and Impact Assessments, and maintain the Site Contamination Control Strategy.
Perform quality risk assessments to evaluate microbial risks, develop mitigation strategies, and support the inspection readiness program, acting as site SME for inspections and global audits.
Required Qualifications
Bachelor’s degree in microbiology or a relevant discipline.
10+ years of experience in the biopharma/pharma industry, with expertise in microbiological and/or adventitious agent contamination control, sterile/aseptic manufacturing and facility design, environmental monitoring, cleaning and disinfection, or a related area.
Deep understanding of sterile manufacturing and microbiological principles within a sterile plant environment.
Experience with Eudralex Annex 1 requirements and technical appraisal, document review, and audits.
Strong analytical and problem‑solving skills.
Excellent written and verbal communication abilities.
Proven experience in root cause analysis and risk management.
Equal Opportunity Employer Statement
As an equal opportunity employer, we embrace diversity and are committed to providing a workplace where all individuals can thrive.
Additional Information
Requisition ID: R395639
Job Posting End Date: 05/12/2026
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