Sterile Microbiology Lead for Launch Readiness

Viatris; Connacht; Presencial; EUR 85.000 - 120.000; Tempo integral

Benefícios oferecidos por esta vaga

Excellent career progression oppor tun

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Resumo da vaga

Viatris is seeking a Microbiology Lead to support a 3-year commercialization program for a new cartridge-filling product line in a sterile manufacturing environment.

You will define microbiology strategies, ensure GMP compliance, oversee environmental monitoring, and collaborate with Quality, Engineering, MS&T to readiness for commercial launch, while driving risk assessments and regulatory submissions.

Qualificações

• Degree in Microbiology, Biology, or related scientific discipline.
• Experience in a sterile or aseptic manufacturing environment.
• Strong GMP, contamination control, and microbiological testing methods knowledge.
• Familiarity with regulatory expectations for sterile products.
• Ability to work in a cross-functional, project-based environment.
• Experience in FDA/IMB regulated facilities (preferably sterile).
• Knowledge of isolator technology.
• Experience with LIMS/gLIMS or MODA.

Responsabilidades

• Provide microbiological oversight across the project lifecycle.
• Define and implement microbiology strategies aligned with sterile manufacturing requirements.
• Ensure GMP, regulatory standards, and data integrity are upheld.
• Oversee environmental monitoring, contamination control, and sterility assurance.
• Support risk assessments related to microbiological and contamination risks with mitigation plans.
• Collaborate with cross-functional teams to ensure readiness for commercial launch.
• Contribute to validation activities including sterilization, aseptic processes, and cleaning validation.
• Support regulatory submissions and inspections as the microbiology SME.
• Maintain department SOPs, change controls, deviations and IRFs.

Conhecimentos

GMP knowledge

Environmental monitoring

Aseptic manufacturing

Regulatory compliance

Cross-functional collaboration

Isolator technology

Regulatory submissions

Formação

Degree in Microbiology, Biology, or a related scientific discipline

Ferramentas

LIMS/gLIMS

MODA

Descrição da vaga

Viatris is seeking a Microbiology Lead to support a 3-year commercialization program for a new cartridge-filling product line in a sterile manufacturing environment.

You will define microbiology strategies, ensure GMP compliance, oversee environmental monitoring, and collaborate with Quality, Engineering, MS&T to readiness for commercial launch, while driving risk assessments and regulatory submissions.