This job posting seeks an Associate Director, Site Sterility Lead at a biopharma facility in Dundalk, Ireland, focusing on aseptic manufacturing and sterility assurance. The ideal candidate will have over 10 years of relevant industry experience and a strong background in microbiology, contamination control, and regulatory compliance
Job Summary
This role offers a high-impact opportunity to shape aseptic standards and mentor operations personnel within a dynamic, multi-product vaccine facility.
The successful candidate will serve as the Subject Matter Expert for site sterility assurance, ensuring alignment with EU GMP Annex 1 and cGMP requirements.
As the site owner of the Environmental Monitoring Program, you will lead microbial investigations and drive site inspection readiness alongside Quality and Operations teams.
Matching Summary
Match Score: 85
This job posting seeks an Associate Director, Site Sterility Lead at a biopharma facility in Dundalk, Ireland, focusing on aseptic manufacturing and sterility assurance. The ideal candidate will have over 10 years of relevant industry experience and a strong background in microbiology, contamination control, and regulatory compliance.
Skills & Requirements
Must-have
Bachelor's degree in microbiology
10+ years biopharma industry experience
EU GMP Annex 1 (2023) expertise
Environmental monitoring program ownership
Root cause analysis and risk management
Aseptic manufacturing knowledge
Nice-to-have
Strong written and verbal communication
Mentoring operations personnel
Driving continuous improvement initiatives
Global audit inspection readiness
Microbiology best practices sharing
Key Requirements
Bachelor's degree in microbiology or relevant discipline
10+ years of experience in Biopharma/Pharma Industry