Senior Microbiology Lead, Sterile Manufacturing

Viatris; Galway; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a microbiology professional to provide oversight across the project lifecycle in a sterile manufacturing environment. This role focuses on defining microbiology strategies aligned with aseptic processes and ensuring GMP compliance and data integrity throughout environmental monitoring and sterility programs.

You will lead cross-functional collaboration with Quality, Engineering, and MS&T, contribute to validation activities, and support regulatory submissions as the

Qualifications

• 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.

Responsibilities

• 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

Skills

GMP compliance

Environmental monitoring

Sterile manufacturing

Cross-functional collaboration

Regulatory knowledge

Isolator technology

LIMS/gLIMS

Data integrity

Education

Degree in Microbiology/Biology or related scientific discipline

Tools

LIMS/gLIMS

MODA

Sterility/Environmental Monitoring equipment

Job description

Viatris is seeking a microbiology professional to provide oversight across the project lifecycle in a sterile manufacturing environment. This role focuses on defining microbiology strategies aligned with aseptic processes and ensuring GMP compliance and data integrity throughout environmental monitoring and sterility programs.

You will lead cross-functional collaboration with Quality, Engineering, and MS&T, contribute to validation activities, and support regulatory submissions as the