Microbiology Lead

Viatris

Inverin, Ireland

The Role & What You Will Be Doing

As Microbiology Lead, you will support the delivery of 3-year commercialization program for a new cartridge-filling product line, providing microbiology expertise within a sterile manufacturing environment. The role will ensure microbiological controls, strategies, and compliance requirements are defined, implemented, and maintained to support successful product development and commercial launch.

Every day, we rise to the challenge to make a difference and here’s how the Microbiology Lead role will make an impact:

Provide microbiological oversight across the project lifecycle
Define and implement microbiology strategies aligned with sterile manufacturing requirements
Ensure compliance with GMP, regulatory standards, and data integrity principles
Oversee environmental monitoring, contamination control, and sterility assurance strategies
Support risk assessments related to microbiological and contamination risks, ensuring appropriate mitigation plans are in place
Collaborate with cross-functional teams (e.g., Quality, Engineering, MS&T) to ensure alignment and readiness for commercial launch
Contribute to validation activities, including sterilization, aseptic processes, and cleaning validation
Support regulatory submissions and inspections as the microbiology subject matter expert
Ensure highest quality standards are maintained in areas of responsibility and that industry best practice is adopted in accordance with current GMP, GLP and regulatory directives.
Responsible for the Microbiology Department SOPs, change controls, deviations and IRFs.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

Degree in Microbiology, Biology, or a related scientific discipline
Proven experience in a sterile or aseptic manufacturing environment
Strong knowledge of GMP, contamination control, and microbiological testing methods
Familiarity with regulatory expectations and standards for sterile products
Ability to work effectively within a cross-functional, project-based environment
Knowledge of working within an FDA/IMB regulated facility (preferably sterile)
Knowledge of isolator technology
Systems knowledge including LIMS/gLIMS, MODA or equivalent
Highly experienced in Environmental Monitoring of a Pharmaceutical Manufacturing Environment