This role requires relocation to Medemblik, Netherlands. Be part of something 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 continuously improve yourself and us – working on challenges that truly matter with people who 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 Quality Engineer for Cytiva is responsible for maintaining the overview of the validated state of products, processes, methods, and equipment. He/She handles deviations of any kind and is the Quality Lead in plant-wide projects. The Quality Engineer will be closely engaged in R&D projects towards the introduction of new products as quality lead. This position is part of the Quality Department located in Medemblik, the Netherlands, 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 support/lead ME/PE to implement/maintain, as a team member, process flow charts, process control plans, process FMEA, and validations. The Quality Engineer is responsible for issuing or reviewing and approving validation documents related to gamma irradiation and product sterility claims.
Coordinate validation activities & development of analysis methods with laboratory contractors. The Quality Engineer supports responses to customer questionnaires, certification requests, and surveys; prepares and maintains/updates standard responses/data for use by Customer Service.
The essential requirements of the job include:
Degree: Master in a scientific field, preferably in Lifesciences (bio, biomedical, chemical, pharma, etc.)
Experience: 3+ years
Language: English (written & spoken)
Skills: Uses analytical mind and data analysis to creatively and pragmatically solve problems, comes up with solutions
Knowledge of quality standards: ISO
It would be a plus if you also possess previous experience in:
Root Cause analysis
QMS
Validation processes
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.
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