QC Microbiology Analyst

Role overview

An opportunity is available for a QC Microbiology Analyst to support a biopharmaceutical site in North Dublin. The role focuses on microbiological testing and sample handling for both drug substance and drug product operations, with particular attention to bioburden and endotoxin in-process testing.

Key duties

• Carry out in-process testing on critical lot-related samples to support manufacturing work.
• Run bioburden testing on utility samples, drug substance, and raw materials within the required hold times.
• Perform bacterial endotoxin testing on utility samples, drug substance, and drug product samples within the required hold times.
• Complete growth promotion checks on media lots entering the laboratory.
• Identify microorganisms recovered after testing activities.
• Perform Minute Mouse Virus PCR testing for in-process samples.
• Support compendial verification, method transfer/validation, and routine testing of in-process, drug substance, and drug product samples in line with approved procedures and cGMP standards.
• Maintain accurate and timely laboratory documentation.
• Work in accordance with standard operating procedures and registered specifications.
• Assist with drafting and reviewing documentation.
• Support other teams so qualification and production timelines stay on track.
• Review laboratory paperwork and reconcile completed analyses.
• Investigate any alert or action limit excursions according to site procedures.
• Follow and help strengthen lean lab and 6S practices.
• Maintain strong standards of housekeeping and laboratory safety.
• Complete other microbiology-related tasks assigned by the Microbiology Manager.

Qualifications and experience

The employer is seeking a candidate with at least a Level 8 qualification in Microbiology or a closely related subject, along with a minimum of 1 year of experience in a pharmaceutical, healthcare, or similar technical laboratory environment. Strong microbiology knowledge and aseptic technique are preferred, as are sterility and bioburden/endotoxin testing experience, though these are not mandatory. Experience with MODA, CIMS, LIMS, LES, and Veeva Vault would also be an advantage. Excellent written and spoken communication skills are required, as is the ability to collaborate effectively in a team-based setting.

Additional information

This is a contract position based onsite in Dublin, County Dublin, Ireland.