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Contamination control and sterility assurance specialist ( d/f/m)

Portsmouth
Cytivalifesciences
€60,000 - €80,000 a year
Posted: 17h ago
Offer description

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 your unique viewpoint matters. 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 vaccines, medicines, and cell and gene therapies.

At Cytiva, you will have opportunities to improve yourself and the organization—working on meaningful challenges with caring colleagues, customers, and patients. Take your next step toward a life-changing career.

Learn about the Danaher Business System, which makes everything possible.


Contamination Control and Sterility Assurance Specialist

This role involves leading and supporting contamination control program improvements under the guidance of Contamination Control and Sterility Assurance Management.


Your responsibilities will include:

1. Developing and implementing a comprehensive contamination control strategy aligned with global standards, ensuring continuous microbiological control and sterility assurance across manufacturing processes.
2. Conducting risk assessments to identify potential contamination sources and developing mitigation strategies, including evaluating existing controls and implementing new measures.
3. Monitoring and analyzing process and product data to identify risks and implement preventive measures.
4. Supporting investigations, CAPA, non-conformances, and change control activities.
5. Maintaining SOPs and work instructions.
6. Preparing technical reports, documentation, and presentations.
7. Participating in audits and inspections to ensure compliance with quality standards.
8. Collaborating with SMEs for data gathering and preliminary analyses.
9. Supporting the development and execution of experimental protocols.
10. Keeping accurate records of project activities.
11. Conducting regular Cleanroom GEMBA and inspections to identify contamination risks.
12. Implementing CAPAs to mitigate risks.
13. Using statistical tools to analyze data and improve processes.
14. Developing and delivering training on contamination control, cleanroom behavior, and hygiene practices.


Who You Are:

* At least 3 years of experience in contamination control, environmental monitoring, cleanroom management, or sterility assurance in pharma, medical devices, or biotech sectors.
* Knowledge of environmental monitoring, microbiological testing, and validation processes.
* Familiarity with standards such as EN ISO 11137-1, BS EN ISO 11737-1, BS EN ISO 14644-1, and others is desirable.
* Strong background in quality assurance, CAPA, and change control processes.
* BSc in Microbiology or related field required.


Preferred Skills:

* Excellent problem-solving and analytical skills with attention to detail.
* Strong organizational skills and adaptability in a fast-paced environment.
* Proactive attitude and willingness to self-learn.

Join our team today. Together, we’ll accelerate the real-life impact of science and technology. We partner globally to solve complex challenges and bring science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and believe in the strength found in differences—visible and not—in our workforce, workplace, and markets. Our associates, customers, and shareholders bring unique perspectives that drive our success.

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