Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher''s 15+ operating companies, our work saves lives-and we''re all united by a shared commitment to innovate for tangible impact.
You''ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher''s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
Working at Cytiva 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. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The Contamination Control and Sterility Assurance Specialist is responsible for leading and supporting contamination control program improvements as directed by Contamination Control and Sterility Assurance Management.
Your responsibilities will include:
Developing and implementing a comprehensive contamination control strategy that aligns with global standards, ensuring continuous improvement in microbiological control and sterility assurance across all manufacturing processes.
Conduct comprehensive risk assessments to identify potential contamination sources and develop mitigation strategies. This includes evaluating the effectiveness of existing controls and implementing new measures as needed
Monitoring and analyzing process and product monitoring and laboratory data to identify risks and implement preventive measures.
Supporting non-conformances, investigations, CAPA, and change control.
Maintenance of standard operating procedures (SOPs) and work instructions.
Supporting the preparation of technical reports, documentation, and presentations.
Assisting in routine audits and inspections to ensure compliance with quality standards.
Collaborating with senior SMEs to gather data and perform preliminary analyses.
Providing support in the development and execution of experimental protocols.
Maintaining accurate and organized records of all project-related activities.
Conduct regular Cleanroom GEMBA and inspections to identify potential contamination risks.
Implement corrective and preventive actions (CAPAs) to mitigate contamination risks.
Analyze data and utilize statistical tools to assess process performance and improve outcomes.
Develop and deliver training programs for operation and other relevant associates on contamination control practices, cleanroom behavior, and hygiene protocols.
Who You Are:
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.
A BSc in Microbiology or a related field is required.
It would be a plus if you also possess previous experience in:
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.
Willingness to engage in self-learning and a proactive "can-do" attitude.
Join our winning team today. Together, we''ll 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.
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