Overview
QC Microbiology Analyst role at MSD in our Commercial Large-Scale Drug Substance Biotech facility in Swords. This position is a critically important activity, ensuring efficient and effective compliant design, construction, qualification, and operation of the Biotech Drug Substance facility in Swords. This role will be responsible for qualifying the Microbiology Quality Control lab and the transfer of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods. This person will be key in the layout of the lab testing flow to ensure the process is streamlined and in line with lean principles.
Responsibilities
* Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
* Perform and carry out a variety of routine microbiological analytical techniques (environmental monitoring, WFI testing, growth promotion testing, in-process product testing, final product testing such as bioburden and both kinetic turbidimetric and MCS rapid endotoxin testing) in compliance with GMP requirements.
* Integrate and complete all documentation on time and be familiar with LIMS. Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
* Support the laboratory testing schedule to achieve an efficient QC system. Receive and manage samples that come into the lab for stability, in-process and release testing.
* Reagent preparation, cleaning, and routine equipment maintenance. Maintain good housekeeping and GLP within the laboratory. Calibrate and maintain all designated laboratory instruments.
* Participate in risk assessments, inspections, audits, incident investigations, and implement and follow-up on corrective / preventative measures.
* Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations. Ensure that cGMP standards are maintained at all times.
* Promote and participate in the implementation and maintenance of the relevant safety programmes.
* Participate and comply with the Quality Management System requirements.
What Skills You Will Need
* Degree qualification (Science/Quality/Technical).
* Minimum 3+ years in a highly regulated drug substance manufacturing environment.
* Experience with routine microbiological analytical techniques and testing.
* Proficient in the use of GLIMS
* Strong problem-solving skills and attention to detail.
Additional Information
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 contact the Talent Acquisition Advisor assigned to this role if you need any support during our recruitment process. We support flexible working where possible and have introduced a new hybrid working model for office-based colleagues around the world. Feel free to discuss what flexibility means to you during your application.
Required Skills: Accountability, Analytical Method Development, Analytical Method Transfer, Bioburden Testing, Environmental Monitoring, GMP Compliance, LIMS, Microbial Assays, QC Microbiology, Quality Management, Regulatory Compliance, Six Sigma, etc.
Preferred Skills: Current Employees apply HERE; Current Contingent Workers apply HERE.
Notes: Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. Relocation, VISA Sponsorship, Travel, and Flexible Work Arrangements information is provided as part of the job posting details. Job Posting End Date: 10/31/2025.
Job Posting End Date: 10/31/2025
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