Job Information
Danaher Corporation Contamination Control and Sterility Assurance Specialist in Cardiff, United Kingdom
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.
Your responsibilities will include:
• Leading and overseeing the microbiological and contamination control processes for cleanroom manufacturing, QC release testing, and other laboratory processes.
• Assisting in the maintenance and validation activities required for the sterility assurance program, ensuring compliance with regulatory requirements, global guidelines, and quality procedures.
• Collaborating with cross-functional teams to provide technical expertise.
• Support the manufacturing site in the development, implementation, and continuous improvement relating to contamination control processes and it impact to sterility assurance, including the design and validation of cleanrooms, equipment, and manufacturing processes.
• Monitoring and analysing environmental monitoring and QC test data to identify trends, deviations, or potential contamination risks, and implementing preventive measures.
• Supporting non-conformances, investigations, CAPA and change control related to the role.
• Writing policies, procedures, and work instructions as required.
• Training and mentoring junior staff as required.
• Monitoring performance indicators and self-developing relevant to the role, ensuring performance management and personal growth.
Who You Are:
• A BSc in Microbiology or a related field is required.
• A minimum of 3 years of experience in contamination control, environmental monitoring, cleanroom management, and sterility assurance within the pharmaceuticals, medical devices, or biotechnology industries.
• Knowledge of environmental monitoring techniques, microbiological testing methods, and validation processes.
• Familiarity with relevant microbiological and sterilization standards such as EN ISO 11137-1, BS EN ISO 11137-2, BS EN ISO 11737-1, BS EN ISO 11737-2, BS EN 17141, BS EN ISO 14644-1, BS EN ISO 11135, and BS EN ISO 10993-7 is desirable.
• A strong background in quality assurance, CAPA and change control processes.
• Willingness to engage in self-learning and a proactive "can-do" attitude.
• Excellent problem-solving and analytical skills with attention to detail.
• Strong organizational skills and the ability to adapt to changing priorities in a fast-paced environment.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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.