A fantastic opportunity has arisen for an Associate Director, Site Sterility Lead to join our expanding team at our company Dundalk. Our facility is dedicated to formulating and filling vaccine products that improve and transform lives globally. This position 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.
Your Key Responsibilities
- You'll 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.
- You'll 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 invaluable guidance to departments including QC and Manufacturing, and driving site inspection readiness and regulatory compliance.
- Share your expertise in microbiology and best practices to ensure compliance and operational efficiency.
- You'll 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.
What You Bring to the Table
Required
- You hold a Bachelor’s degree in microbiology or a relevant discipline.
- With 10+ years of experience in the Biopharma/Pharma Industry, you're well-versed in one or more of the following areas: microbiological and/or adventitious agent contamination control, sterile/aseptic manufacturing and facility design, environmental monitoring, cleaning and disinfection, or a related area.
- You excel in sterile manufacturing and have a strong understanding of microbiological principles and practices in a sterile plant environment.
- Expertise in Eudralex Annex 1 requirements and experience in technical appraisal, document review, and audits.
- Your analytical and problem-solving skills are top-notch.
- Strong written and verbal communication abilities set you apart.
- Proven experience in root cause analysis and risk management.
Required Skills:
Biopharmaceutical Industry, Communication, Contamination Control, Driving Continuous Improvement, Environmental Monitoring, Microbiology, Operational Efficiency, Sterility Assurance, Technical Writing
