Job Information
Danaher Corporation quality engineer - cleanliness & sterility in Beijing, China
Be part of something altogether life-changing!
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. 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.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The contamination control and sterility assurance (CCSA) quality engineer for Cytiva is responsible for leading site cleanliness control activities, ensuring on-time master set testing and driving CCSA improvement.
This position is part of the quality assurance team located in Shunyi, Beijing and will be on-site. At Cytiva, our vision is to advance future therapeutics from discovery to delivery.
In this role, you will have the opportunity to:
Implement contamination control & sterility assurance actions at site
Participate in global CCSA community, perform site assessment, learn best practices and lead site improvement
Ensure master set testing and documentation per plan for product claims:
Plan master set testing for all site products; Ensure production orders for master set samples are released on time; Send master sets to respective testing and irradiation locations; Track sample status and collect test results; Document test results for product claims.
Answer customer inquiries and audit questions on product cleanliness & sterility.
Support site projects, initiatives, and external audits.
The essential requirements of the job include:
Bachelor or Master in a scientific field, preferable in Life Sciences, e.g. bio, biomedical, chemistry, chemical, pharma, …
Minimum five years of relevant experience in pharmaceutical, medical device or other regulated industry
Willing to collaborate with cross-functional team toward a common goal
It would be a plus if you also possess previous experience in:
Track record of working in a cleanroom environment
Certified internal auditor for ISO 13485
Project management experience
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.