Process Engineer, Global Biologics
AstraZeneca / Processoperatörsjobb (kemisk basindustri) / Södertälje
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hela Sverige AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
We have an exciting opportunity for someone to join our new Biologics facility based in Södertälje, Sweden.
The role
The Process Engineer will be accountable for combination products devices, ensuring that Sweden Biologics Facility's License to Operate is maintained by managing quality, manufacturability and supply chain for key devices which are used and supplied by Sweden Biologics.
Accountabilities/Responsibilities
* Ensure that the Sweden Biologics Facility has appropriate procedures, standards and guidance to address the regulatory and operational requirements of combination products and their devices
* Ensure that projects and changes at the Sweden Biologics Facility or within the upstream devices supply chain are appropriately understood, controlled and adhere to the appropriate standards for combination products and devices
* Responsible for ensuring consistent best practice for combination product and device management is used across the Sweden Biologics Facility. For example, Change Management, Technical training, Knowledge Management and Supplier Management
* Maintain a detailed understanding of the supply chain for devices and assess the capabilities and vulnerabilities
* Understand the technical specifications that define the quality and manufacturability of combination products including devices at the Sweden Biologics Facility
* Provide technical expertise and manufacturing insight into the development of prototypes and concepts for new or significant changes to devices relevant to the Sweden Biologics Facility operations
Minimum experience
* To have a minimum of science / engineering degree or equivalent
* Experience of the commercialisation and life cycle management of combination products
* Experience with device technology, standards and quality requirements
* Experience of device assembly equipment and cGMP manufacturing process
* Good understanding of combination products regulatory requirements, device development process and human factors
Preferred experience/requirements
* Knowledge and experience of vial and syringe glass primary containers, glass defect characterisation and glass breakage root cause analysis
* Knowledge and experience of secondary packaging design for devices
* Experience of device assembly equipment vision systems
More information
For more information about the position please contact hiring manager Martin Hunter + 46 8 552 503 52.
Welcome with your application no later than February 25, 2018.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-02-02ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-02-09
Ange följande referens när du ansöker: R-021976
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
Helena.Kallin@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
15185
15185 0181
KontorsadressAstraallén
Jobbnummer 3941604
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