Sterility Professional
Cytiva Sweden AB / Kemiingenjörsjobb / Uppsala
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hela Sverige 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
Responsible for the development and continuous improvements of the Uppsala sterility assurance program and related work instructions.
Responsible for directing cross-functional associates on the implementation of sterility assurance global procedures, local work instructions and monitoring effectiveness.
Build and maintain a sterility assurance program that enables effective stakeholder transparency to program requirements, status of deliverables and any risks.
Develop a sterility assurance coaching program for relevant associates who support sterilization processing/release, cleanroom environmental monitoring and sterile validation requirements.
Monitor external & internal changes to sterility assurance requirements ensuring any impact to the Uppsala Quality Management System is managed accordingly, including responsibility for supporting Sterile supplier selection & qualification.
Who you are
Bachelor's degree in Microbiology, Biology, or Biomedical engineering discipline with at least 6 years of experience supporting sterility assurance management in medical device, biotech, or pharmaceutical industries. MSc or PhD qualified, desired.
Must have a high technical knowledge of ANSI/AAMI, USP & ISO Sterility Assurance & Cleanroom standards, including ISO11137, ISO14644, ISO14698, ISO17665, ISO16775 with demonstrated experience.
Have experience of product validations using Gamma and Moist Heat sterilisation methods.
Have leadership experience.
Must have effective verbal and written communication (Swedish and English), strong networking skills and be experienced in technical reporting.
Experienced in Sterility Assurance validation, Risk - and CAPA management.
Demonstrate ability to handle multiple assignments simultaneously and effectively.
Ability to work highly independently.
This position is based at our site in Uppsala, Sweden. We apply a hybrid work model which allows for the flexibility to work from home.
Our business is growing quickly and we hire across the board. Interviews and selection will happen continuously, we look forward to your application today!
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 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.
Publiceringsdatum2021-11-04Så ansöker duSista dag att ansöka är 2021-12-04
Klicka på denna länk för att göra din ansökanAdressCytiva Sweden AB
Björkgatan 30
75184 Uppsala
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Cytiva Sweden AB (org.nr 556108-1919)
Björkgatan 30 (
visa karta)
751 84 UPPSALA
Arbetsplats Cytiva Sverige AB
Jobbnummer 6097106
Observera att sista ansökningsdag har passerat.