Manager, Device Engineering
at Alexion PharmaceuticalsInc
Dublin, County Dublin, Ireland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 26 Dec, 2024 | Not Specified | 28 Sep, 2024 | N/A | Good communication skills | No | No |
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Description:
Responsibilities:
THIS IS WHAT YOU WILL DO:
The Manager, Device Engineering is responsible for technical support of device/finished product manufacturing for commercial products and provides device engineering support through all phases of the commercial device/finished product (FP) lifecycle. This includes design transfer, validation, and routine device/FP commercial manufacturing.
Serves as a subject matter expert for the FP aspects of device assembly and device activation for external device/FP manufacturing for Alexion commercial products applying drug delivery devices as the programs/products transition into commercial products.
YOU WILL BE RESPONSIBLE FOR:
- Collaborate with R&D during development to ensure product & process requirements are identified, and robust specifications are generated.
- Perform Device/Finished Product (FP) design transfer for assigned projects into cGMP commercial external device/FP manufacturing facilities.
- Perform process evaluation, facility fit analysis and identification of equipment required for new device/FP manufacturing processes, either independently or in partnership with external device/FP manufacturing personnel.
- Support alignment of device/FP processes across internal and external device/FP manufacturing sites.
- Support resolution of complaints and liaise with device vendor(s) to resolve issues, investigations, and implement continuous improvements.
- Author / review device/FP design transfer documentation; e.g. validation run protocols, and technical study protocols.
- Provide device/FP SME input for regulatory agency submission in support of device/FP manufacturing process operated at external FP manufacturing sites.
- Perform technical assessments to support business needs e.g. non-conformities, deviations, CAPA and change management (design, process and document changes)
- Provide device engineering expertise in trouble shooting activities to support manufacturing during device/FP design transfer activities or routine device/FP manufacturing.
- Identify and lead device/FP process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of device/FP and device assembly manufacturing.
- Identify device/FP manufacturing best practices across the network and lead or participate in teams to implement best practices.
- Collaborate effectively with other team members in cross functional technology transfer teams, including with device/FP external manufacturing partners and internal device/FP manufacturing stakeholders.
- Implement business process improvements with a continuous improvement mindset for device/FP manufacturing support and device/FP tech transfers.
- Partner with product teams on optimal device design considering the end user/patient, supply chain, and device/FP manufacturing network capabilities.
- Partner, own and provide input with business partners on the development and maintenance of stage relevant device and combination product lifecycle documents..
- Partner with quality on maintaining lifecycle documents for devices and combination products.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Mechanical or Industrial Engineering
Engineering Design / R&D
Mechanical Engineering
Graduate
Engineering (or similar technical degree
Proficient
1
Dublin, County Dublin, Ireland