Technical Lead Qualifications Services
vor 2 Monaten
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 Technical Lead Qualifications Services (d/f/m) for Cytiva is responsible for creating content to help document the qualification of Cytiva equipment on the customer site.
This position is part of the Qualification Services team and is located at the Dreieich facility in Germany and will be based onsite. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
Supporting project management, automation and NPI team projects within Qualification Services (QS) business with creation and management of technical aspects of master document templates.
Manage and lead the technical generation of content for multiple programs within the Qualification Services business.
Creation of quality Commissioning and Qualification (C&Q) documentation from system technical/design documents and guidance from subject matter experts.
Analyse software and hardware changes to determine impact on current offering or requirement for additional testing.
Support the broader QS team in customer facing projects.
Who you are:
Degree in Engineering or significant technical/quality service background.
Familiarity with 21 CFR Part 11, GAMP 5, Annex 11, GxP, and other regulatory standards. Minimum of 4 years of healthcare experience.
Ability to understand and interpret technical product documentation.
Experience working within a QMS environment to ensure quality standards in commissioning and qualification documentation.
Able to work with a global team to meet project goals within agreed timelines.
Fluent in spoken and written English, German is a plus
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Willingness to travel globally, up to 25% of the time
It would be a plus if you also possess previous experience in:
Demonstrated capability in performing execution of Commissioning and Qualification of large complex custom and/or Flex Factory Projects.
Understanding and experience of field service actions for multiple Cytiva system platforms.
Experience in creating and/or executing validation and verification documentation.
#LI-onsite
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.
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