Job Information
Danaher Corporation quality engineer - validation 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 validation quality engineer for Cytiva is responsible for owning site validation master plan & its execution and managing site validation activities.
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:
Manage site validation master plan and its on-time execute by working with cross-functions.
Maintain site validation master plan and site validation list to cover all products and processes at site.
Guide local team to conduct and document validation activities to meet global requirements and customer expectations.
Provide validation training and share best practice with site functions.
Support validation work for product transfer projects.
Support commissioning & validation for new facility, equipment, instruments and tools.
Support process flow charts, process control plans and process FMEA activities.
Answer audit questions and customer inquiries on site validation.
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
Demonstrated ability to own and drive validation planning and execution.
Willing to collaborate with cross-functional team toward a common goal
It would be a plus if you also possess previous experience in:
Certified internal auditor for ISO 13485
Project management experience
Seek creative and/or innovative solutions to a known problem
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.