Manufacturing Science & Technology Device Engineer, Astrazeneca
AstraZeneca AB / Civilingenjörsjobb / Södertälje
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hela Sverige Are you a person who loves cross-functional collaboration and leading continuous improvements? Are you looking for a chance to make a difference for people worldwide? Then your future starts with us!
The Sweden Biomanufacturing Center (SBC) is a strategic investment to support the AstraZeneca biologic product portfolio. The new manufacturing facility will have the capability to support the Astra Zeneca biologic commercial pipeline and biologic clinical trial and launch programmes. At Sweden Biologics we shape the future by delivering advanced and sustainable biological drugs.
We operate in a multicultural and global environment where revolutionary digital solutions propel us forward. Looking to the future, our challenge now is to sustain and improve our effort, by establishing Lean as the behavior that underpins our vision so that the Global Operations teams align with Lean and how it will underpin our future success.
If you have the passion and the drive to accelerate growth and make people's lives better then this is the place for you.
We now offer an exciting opportunity to join our new start-up biologics manufacturing plant located in Södertälje, as MS&T Device Engineer.
Business Area
Manufacturing Science & Technology (MS&T) is the bridge that turns innovative science into actual medicines that help millions of people. The MS&T function ensures reliable and flexible formulation, filling, visual inspection, device assembly, bulk and final packaging of late stage clinical and commercial products, in order for SBC to become the preferred supplier for late stage clinical and commercial products. We also provide expert technical support for AstraZeneca's commercial biologic drug products.
As the MS&T Device Engineer for AstraZeneca SBC you will be part of a team with as a specialist in process development and transfer activities for the assembly of Combination Products and Medical Devices, which may include but is not limited to accessorized prefilled syringes and auto-injectors.
The MS&T Device Engineer will assure a compliant and effective assembly process development through the establishment of process steps and associated operational design space to deliver an appropriate control strategy for late stage clinical and commercial products. Furthermore, the MS&T Device Engineer will provide technical expertise for device material specifications, incoming inspection procedures and assessment of the interaction between material components and equipment. You will work in a global environment transferring a wealth of New Product Introductions to the SBC manufacturing facility.
What you'll do
You will serve as the Combination Product/Medical Device Subject Matter Expert for Technology Transfers, Design Transfer, and Investment/Improvement Projects for recent technology and capability builds. You will lead or participate as a Combination Product/Medical Device Subject Matter Expert in risk assessments, change controls and deviation investigations in collaboration with external and internal customers and suppliers. You will also be the Combination Product/Medical Device technical workstream lead in projects by organizing and leading a cross functional teams to deliver to project timelines.
Essential Requirements
You need to have led cross functional teams preferably in a global environment. Key competences are strong problem solving and communication skills. You need to have a "can do" attitude with experience of delivering successful project outcomes on time. Furthermore, you should be competent in technical writing and data analysis.
The MS&T Device engineer will be expected to have a relevant experience in biologics and/ or pharmaceuticals, engineering and/or manufacturing holding a MSc or BSc degree.
To be successful in this role you need to have experience working with manufacturing Combination Products and/or Medical Device lines, assembly processes and device components in a cGMP environment.
Desired requirements
* Technology Transfer and/or Design Transfer Experience
* Equipment Qualification, Process Validation and/or Shipping Validation Experience
* Experience working with Combination Products and/or Medical Devices
* Worked in a LEAN environment
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines to our patients is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Are you already imagining yourself joining our team in Södertälje? Good, because we can't wait to hear from you.
More information
For more information about the position please contact Kristina Köhler, MS&T Lead, at +46722051246 or +46855254060.
Welcome with your application no later than September 26th, 2021. Interviews will be held ongoing during the application period.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2021-09-08ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2021-09-15
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-118781".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5953008
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