OBS! Ansökningsperioden för denna annonsen har
Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
We are looking for a Sterility Assurance professional to lead the Sterility Assurance program at the Uppsala Site, reporting to the Site QA Leader. This is a key technical role requiring domain expertise related to sterile product validation & manufacturing controls including terminal sterilization, controlled environments and related microbiology testing. If you have demonstrated experience of building & leading Sterility Assurance programs, then we would love to hear from you.
What you’ll do
Support with 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.
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.
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.
Our business is growing quickly and we hire across the board. Interview and selection will happen continuously and an opening can be filled before last day of application, which is 19th of November.
Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!
Kontaktpersoner på detta företaget
Rekryteringsansvarig Lars Due-Sørensen
+47 67 21 36 49