Senior Manager Sterility Assurance

1100 Mylan Pharmaceuticals Inc.; Galway; On-site; EUR 120,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Pension

Excellent career progression

Work-life balance initiatives

Bonus scheme

Job summary

Viatris is seeking a Senior Manager Sterility Assurance to drive sterility and contamination control across aseptic manufacturing. The role integrates microbiology leadership with global regulatory compliance to safeguard injectable products.

You will collaborate with Quality, Manufacturing and Engineering to strengthen aseptic processes, monitor KPIs and guide investigations with robust CAPAs. A senior, hands-on microbiology expert is required.

Qualifications

• Bachelor’s degree (or higher) in Microbiology or related field.
• Extensive experience in sterility assurance, aseptic manufacturing, or related areas.

Responsibilities

• Lead site Sterility Assurance strategy and program per EU GMP Annex 1 and global regs.
• Develop and maintain Contamination Control Strategy (CCS).
• Conduct risk assessments for aseptic processes and environmental monitoring.
• Oversee environmental monitoring and contamination control programs.
• Lead microbiological investigations with root cause analysis and CAPA.
• Coordinate and oversee aseptic process simulations (media fills).
• Support validation/qualification activities for sterility testing and aseptic processes.
• Represent sterility assurance in audits and regulatory inspections.

Skills

Sterility assurance

Microbiology

Environmental monitoring

Aseptic processing

Regulatory audits

Risk assessment

Isolator technology

Excel

Project management

Education

Bachelor’s degree in Microbiology or related field

Tools

MODA

CAPA tooling

Job description

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. 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

Senior Manager Sterility Assurance plays a pivotal role in ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies. This role extends beyond microbiological testing to encompass comprehensive oversight of aseptic manufacturing, contamination risk management, and adherence to global regulatory requirements. It involves close collaboration across departments to drive sterility assurance initiatives while fostering a culture of quality excellence

Key Responsibilities

• Lead the site Sterility Assurance strategy and program, ensuring compliance with EU GMP Annex 1 and global regulatory requirements.
• Develop and maintain the Contamination Control Strategy (CCS) to support sterile manufacturing operations.
• Conduct risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks.
• Oversee and continuously improve the environmental monitoring program to ensure robust contamination control.
• Lead and support microbiological investigations, ensuring appropriate root cause analysis and effective CAPA implementation.
• Coordinate and oversee aseptic process simulations (media fills) and support review and approval of related documentation.
• Support validation and qualification activities related to sterility testing, aseptic processes, and laboratory systems.
• Represent sterility assurance in internal and external audits and regulatory inspections, addressing observations and driving corrective actions.
• Collaborate cross-functionally with Quality, Manufacturing, Engineering, and Microbiology teams to ensure alignment on sterility assurance practices.
• Maintain and approve key sterility assurance documentation, including SOPs, validation protocols, and contamination control plans.
• Monitor and report sterility assurance performance metrics and trends, driving continuous improvement across the site.

About Your Skills & Experience

The successful candidate will have the following qualifications, skills, and experiences: A Bachelor’s degree (or higher) in Microbiology or a closely related field (e.g., Biotechnology). Extensive years of experience in sterility assurance, aseptic manufacturing, or a related field, with a strong emphasis on microbiology and contamination control is needed. Aseptic Process Expertise: Proven experience in contamination control strategies, including cleaning and disinfection validation. Hands-on experience with isolator technology, environmental monitoring, and aseptic processing validations... (List areas of Knowledge required Deep understanding of Annex I, US, and EMA GMP regulations and their application in sterility assurance Hands-on experience in regulatory audits, with a solid track record of compliance and audit readiness in sterile environments. Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives. Risk Assessment & Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions. Technical Proficiency: Proficient in the use of contamination control tools and monitoring systems, including MODA, Excel, and project management software. Communication & Collaboration: Excellent ability to articulate sterility assurance concepts and collaborate cross-functionally to drive compliance and process improvements. This is a senior role that requires an in-depth understanding of microbiological principles as they apply to sterility assurance. You will play a critical role in ensuring the highest standards of aseptic manufacturing, contamination control, and compliance across our production processes. If you have a pure microbiology background and bring extensive hands-on experience in sterility assurance, we’d love to hear from you. At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at Viatris

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

Viatris is an Equal Opportunity Employer.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.