Position Summary

The Device Engineer / Technical Transfer Lead is responsible for technical support for Combination Product / Finished Product manufacturing for clinical/commercial products. The Device Engineer / Technical Transfer Lead is responsible for providing device engineering support through all phases of the clinical / commercial Combination Product / Finished Product (FP) lifecycle, including technology transfer, validation, and routine device/FP manufacturing.

The Device Engineer/Technical Transfer Lead is responsible for leading the technology transfer for devices to internal device/FP facilities for a clinical/commercial product, and technical support for routine internal device/FP manufacturing for multiple clinical/commercial products. The position requires effective cross-functional collaboration with external and internal partners including internal device/FP subject matter experts, Alexion technical Operations, device development team, New Product Introduction (NPI) team, Engineering, Operations, Quality, and Regulatory partners.

The Device Engineer/Technical Transfer Lead will serve as a subject matter expert for the FP aspects of device assembly and FP for internal device/FP manufacturing for Alexion products utilizing drug delivery devices as the programs/products transition into commercial products.

Principal Responsibilities

• Lead Device/Finished Product (FP) design / technical transfer for assigned projects into cGMP clinical/commercial internal device/FP manufacturing facility
• Responsible for performing 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.
• Support Packaging Operations in the development of MBRs, PI and SOPs for the manufacture of devices/FP.
• 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.

Qualifications

• Minimum of five years’ experience in providing technical support to device manufacturing (technology transfer or routine cGMP manufacturing)
• Comprehensive knowledge of device/Finished Product manufacturing operations including pre-filled syringes, autoinjectors, injection pens, combination products and design control/technical documentation.
• Good understanding of cGMP requirements for clinical/commercial device manufacturing and the lifecycle management of combination products and medical devices (e.g., ISO 13485. ISO 14971, 21CFRPart4/21CFR820 and EUMDR).
• Proven ability to work independently and to build highly effective relationships both within and external to the company
• Organized analytical thinker wi th strong attention to detail
• Excellent oral and written communication skills, including technical writing and presenting technical data, and technical reports.

Education

• Minimum of bachelor’s degree in engineering (or similar technical bachelor’s degree) (advanced degree preferred)

Date Posted

16-Oct-2024

Closing Date

05-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.