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Danaher Corporation Manager, Microbiology and Sterility Assurance in Uppsala, Sweden

Be part of something altogether life-changing

Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

We are looking for a Manager, Microbiology & Sterility Assurance to support and maintain end to end microbial assurance activities and terminal sterilization processes (Radiation & Moist Heat) for new and existing products and manufacturing processes in Uppsala, Sweden reporting directly to Global Sterility Assurance Director.

What you’ll do

The Microbiology and Sterility Assurance function are responsible for assuring products and processes are qualified and maintained to an acceptable level of microbiological quality in accordance with local and global procedures, regulatory and customer requirements. The function are subject matter experts in microbiology and sterilization and are a key support function to R&D, manufacturing and supply chain supporting security of supply.

  • Supervise and develop a team of subject matter experts in microbiology and sterilization.

  • Support creating and setting performance and development for growth objectives for direct reports.

  • Manage a headcount and expense budget for the area

  • Be management representative and supporting decision maker for microbiology and sterility assurance for site.

  • Coordinate resources and set daily priorities for the team in line with team and site objectives.

  • Own and create SOPs/local policies to ensure clear roles, responsibilities and decision-making authority between functional areas.

  • Create and maintain a pipeline of continuous improvement activities to feed into the Uppsala site Danaher Business Systems (DBS) Kaizen activities.

  • Responsible for the performance qualification and ongoing periodic reviews of cleanrooms, autoclaves and radiation sterilization processes.

  • To own and maintain the training curriculum for site with respect to microbiology and sterility assurance. To work with cross functional leaders on training programs for key site stakeholders

  • Provide SME support for customer and regulatory audits related to contamination control and sterility assurance.

  • Provide microbiology & sterility assurance support to key site projects including new product introductions, product care and security of supply ensuring compliance with Cytiva policies, industry best practice and customer and regulatory requirements.

  • Drive corrections and corrective actions alongside key stakeholders/support functions to ensure timely implementation.

  • Responsible for non-conforming product process, root cause analysis, CAPA and complaint investigations for microbial control & sterility assurance related problem solving.

  • Provide support and consultancy to qualification of critical processes such as water systems and process hygiene/cleaning.

  • To be up to date on relevant internal and external standards and documents relevant to the area of responsibility

  • Provide microbiological review and approval of validation plans and reports.

  • Assess microbiological impact in Change Control cases and planned deviations

  • Assess deviations with respect to microbiological/hygienic impacts

Who you are

  • University of Science or Technology in a scientific discipline such as microbiology, biology or related field.

  • Experience from leading and developing a team

  • Experience from working with production hygiene and cleanrooms

  • Experience from the life science or pharmaceutical industry

  • Excellent oral and written presentation in Swedish and English

  • Experience from project management or project work

  • Terminal sterilization experience desired but not necessary.

The role will be a hybrid (on site and remote) working model in line with business needs. Selection, interviews and recruitment will take place continuously.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.