Sterile Microbiology Lead: Guide Launch & Compliance

Viatris; Inverin; Presencial; EUR 70.000 - 100.000; Tempo integral

Benefícios oferecidos por esta vaga

Health insurance

Pension

Bonus scheme

Career progression

Work-life balance

Resumo da vaga

Mylan Teoranta, a Viatris company, is seeking a Microbiology Lead to support a 3-year commercialization program for a new cartridge-filling product line. You will provide microbiology expertise in a sterile manufacturing environment, defining controls and compliance for product development and launch.

You will oversee environmental monitoring, risk assessments, and collaboration with Quality, Engineering, and MS&T to ensure readiness for commercial launch.

Qualificações

• 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 for sterile products.
• Ability to work within a cross-functional, project-based environment.
• Experience in FDA/IMB regulated facilities (sterile preferred).
• Knowledge of isolator technology and associated systems.

Responsabilidades

• Provide microbiological oversight across the project lifecycle.
• Define and implement microbiology strategies for sterile manufacturing.
• Ensure compliance with GMP, regulatory standards, and data integrity.
• Oversee environmental monitoring, contamination control, and sterility assurance.
• Support risk assessments and mitigation for microbiological risks.
• Collaborate with Quality, Engineering, MS&T for readiness for launch.
• Contribute to validation activities including sterilization and cleaning validation.
• Support regulatory submissions and inspections as SME in microbiology.
• Maintain high quality standards and align with industry best practices.

Conhecimentos

Microbiology

GMP knowledge

Environmental Monitoring

Regulatory understanding

Cross-functional teamwork

Sterile/aseptic manufacturing

LIMS/gLIMS systems

Sterility assurance

Formação

Degree in Microbiology or related

Ferramentas

FDA/IMB regulations

Descrição da vaga

Mylan Teoranta, a Viatris company, is seeking a Microbiology Lead to support a 3-year commercialization program for a new cartridge-filling product line. You will provide microbiology expertise in a sterile manufacturing environment, defining controls and compliance for product development and launch.

You will oversee environmental monitoring, risk assessments, and collaboration with Quality, Engineering, and MS&T to ensure readiness for commercial launch.