1 day ago Be among the first 25 applicantsJob DescriptionA 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 ResponsibilitiesDrive excellence in sterile manufacturing through expert training, coaching, and oversight of cleanroom behaviors, contamination control, and sterile techniques.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 concerns, providing invaluable guidance to departments including QC and Manufacturing.Share expertise on microbiological procedures 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.What You Bring to the TableHold a Bachelor’s degree in microbiology or a relevant discipline.10+ years of experience in the Biopharma/Pharma Industry, with expertise in site microbiology or a related area.Strong experience in sterile manufacturing and a deep 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.Strong analytical and problem‑solving skills.Excellent written and verbal communication abilities.Proven experience in root cause analysis and risk management.Reporting ToSite Quality HeadRequired SkillsBiopharmaceutical Industry, Communication, Contamination Control, Driving Continuous Improvement, Environmental Monitoring, Microbiology, Operational Efficiency, Sterility Assurance, Technical WritingLegal StatementsWe keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.Please don’t hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during the recruitment process.We are committed to flexible working where possible, and this is why our company has introduced a new hybrid working model for office‑based colleagues around the world.Invent solutions to meet unmet healthcare needs, please apply today.
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