Microbiology Lead

1528 Mylan Teoranta; Galway; Presencial; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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

Conocimientos

GMP compliance

Environmental monitoring

Sterile manufacturing

Cross-functional collaboration

Regulatory knowledge

Isolator technology

LIMS/gLIMS

Data integrity

Educación

Degree in Microbiology/Biology or related scientific discipline

Herramientas

LIMS/gLIMS

MODA

Sterility/Environmental Monitoring equipment

Descripción del empleo

Mylan Teoranta Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

• 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

• 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

Benefits at Viatris At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viastis is an Equal Opportunity Employer. Viatris is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, and Hyderabad, India.