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.
Your 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, 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.
Required
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 the 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) Job Description
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.
Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our 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.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to
Invent solutions to meet unmet healthcare needs,
please apply today.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Not Applicable
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
01/19/2026
* A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID
R377618