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Site Sterility Lead, Associate Director
role at
MSD Ireland
Job Description
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.
Key Responsibilities
You'll drive 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 *****), 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 concerns, providing invaluable guidance to departments including QC and Manufacturing.
Share your expertise on microbiological procedures 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
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 site microbiology 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.
Reporting to
Site Quality Head
Required Skills
Biopharmaceutical Industry
Communication
Contamination Control
Driving Continuous Improvement
Environmental Monitoring
Microbiology
Operational Efficiency
Sterility Assurance
Technical Writing
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s)
We 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.
Location
Dundalk, County Louth, Ireland
Requisition ID
R
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