Danaher Corporation Technical Lead, Qualification Services in Bromma, Sweden
Be part of something altogether life-changing
Working at Cytiva in the Life Sciences industry 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.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
What you’ll do
Support 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
Analyze software and hardware changes to determine impact on current offering or requirement for additional testing.
Adaption to and development of best practices of documentation processes.
Communicate current state to senior management to secure deliverables.
Work cross functionally within the company to maintain quality in a growing business
Support the QS Commercial Team to determine that the correct C&Q documents will be quoted to match the customer’s needs.
Support the broader Qualification Services team in customer facing projects
Who you are
Bachelor’s degree in Science, Engineering or related area with relevant work experience.
Understanding of Regulatory and Quality requirements. Familiarity with 21 CFR Part 11, GAMP 5, Annex 11, GxP and other regulatory standards with Healthcare experience of minimum 4 years.
Ability to understand and interpret technical product documentation without guidance.
Familiar with and demonstrated ability to work within a QMS environment to drive quality standards in the commissioning and qualification documentation.
Demonstrated capability in performing execution of Commissioning and Qualification of large complex custom and/or FlexFactory Projects.
Deep understanding and experience of field service actions for multiple Cytiva system platforms.
Ability to work remotely to meet project goals within agreed timelines.
Works in a systematical and structured way.
Experience of working in a global environment.
Fluent in spoken and written English
Our business is growing quickly and we hire across the board. Interviews and selection will happen continuously, we look forward to your application today!
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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.If you’ve ever wondered what’s within you, there’s no better time to find out.