Manager, Device Engineering

at  Alexion PharmaceuticalsInc

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.