Sterility Assurance Manager / Aseptic Lead
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Sterility Assurance Manager / Aseptic Lead
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Sterility Assurance Manager / Aseptic Lead
Our client is a leading global healthcare company dedicated to enhancing health and quality of life for people worldwide. Operating in over 110 countries, the company develops, manufactures, and delivers innovative healthcare solutions for patients living with chronic, rare, and life-threatening conditions. Its core therapeutic focus spans immunology, infectious diseases, pulmonology, and critical care.
The company's state-of-the-art sterile manufacturing facility in Dublin serves as a strategic global hub for its biopharmaceutical operations, supporting the production of high-quality, life-saving treatments.
The Position:
* Act as Subject Matter Expert (SME) on aseptic filling operations.
* Lead site-wide sterility assurance initiatives and contamination control strategies.
* Oversee cleanroom design, aseptic process simulations (media fills), and environmental monitoring (EM).
* Develop and maintain aseptic standards aligned with EU GMP Annex 1 (2023), Annex 15, and cGMP.
* Design and implement training and requalification programs on aseptic techniques and behaviours.
* Provide coaching and mentorship to supervisors and operations teams.
* Maintain audit and inspection readiness.
* Represent the site during regulatory inspections and governance forums.
* Support CAPA implementation and investigation processes related to sterility and compliance.
* Lead sanitation programs and cleanroom operations.
* Contribute to cross-functional projects and overall business needs, including taking leadership roles in other operational areas as needed.
* Ensure aseptic SOPs, OJTs, and documentation are accurate and current.
* Promote a culture of continuous improvement, safety, and technical excellence.
The Person:
* Bachelor's Degree in microbiology or related field.
* At least 5 years' experience in a sterile manufacturing environment.
* Strong knowledge of aseptic manufacturing, contamination control, sterilization, and EM.
* Deep understanding of regulatory frameworks including EU GMP (Annex 1 & 15), EudraLex Vol 4, and cGMP.
* Proven leadership and mentoring skills.
* Experience in developing and running training programs.
* Strong interpersonal and cross-functional collaboration skills (e.g., Quality, Validation, Operations, Engineering).
* Facility start-up experience (desirable).
To learn more about this role apply online or contact Trisha Bracken on + 353 87 344 9559 | Email: trisha.bracken@hrmrecruit.com for a confidential discussion.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Manufacturing, Quality Assurance, and Science
* Industries
Chemical Manufacturing, Chemical Raw Materials Manufacturing, and Pharmaceutical Manufacturing
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