Senior Packaging Design Engineer

This is what you will do:

Reporting to Head of Packaging Operations. Responsible for GMP finished product manufacturing technical operations at the Alexion Dublin Manufacturing Facilities in Ireland.

This responsibility includes management of the design, development and updates of the labeling and packaging components across current products and future products, both commercial and clinical.

Streamline the packaging processes to match the component designs (equipment, layout, flow, systems, component fit/shape, etc.), with the full understanding of the:

a) equipment, b) manufacturing process, c) component design, d) vendor relationship (design abilities) and e) customer needs and requirements.

The position will provide leadership as the packaging SME for the design and updating of the new and existing finished product components and in streamlining the packaging equipment/process to ensure synergy between the equipment, components, and customer needs.

The role will partner with staff; foster effective cross-functional working relationships with Quality Assurance, Alexion Technical Operations, NPI Department, Quality Control, Engineering/Maintenance and Automation which support day-to-day operations for component design and issues; interact with Process Development, Artwork Department and procurement for clinical and production components; and provide support for regulatory submissions. This role is responsible for developing  lean manufacturing processes to maximise the supply of the best components most suited to Alexion/AZ and its customer needs  at the Dublin facility.

You will be responsible for:

• Provide technical and people leadership to the design and development of the new finished product components used at ADMF, by designing, prototyping, and testing packaging solutions that are functional, aesthetically pleasing, and cost-effective
• Design packaging components, so they function on manual and automated packaging lines, including high speed packaging, Ensuring all packaging designs comply with industry and regulatory standards
• Work with packaging operations to ensure the packaging team are happy with the component design and its function.
• Collaborate with vendors onsite and offsite to ensure the the optimal design is achieved (material and function) so as to ensure supply is guaranteed with approved vendors.
• Creating specifications, artwork, prototypes, and samples for new packaging designs, addressing any issues or complaints related to packaging and implementing necessary changes
• Work with supporting departments to ensure the component designs are functional and supported by the ADMF internal departments.
• Manage/support Engineering trials for packaging components in the packaging area.
• Work on process improvements related to the components designed so as to lean out the process and revise the component design to help streamline the use of the various components in use in the packaging department.
• Collaborate with operators to use their knowledge to improve the component design and ways to help their handling of the components.
• Work closely with engineering support operation of the equipment in a manner best suited to the use of the components, operators, and customer needs.
• Create all technical drawings (trial purposes and/or commercial ready) for ADMF components up to and including effective.
• Work using CAD drawings (vendor and ADMF) supplied for the development of various components.
• Organise the transfer of technical drawings into E-Room for vendor access.
• Create Gazelle profiles for new component designs.
• Work with the NPI/Artwork team on Gazelle profiles for the ADMF site, as and when required.
• Work with Procurement Department when selecting new vendors or managing existing vendors, where technical support is required.
• Work with Engineering/Maintenance, Technical Services, Process Development and Procurement to ensure efficient management of Alexion's components for finished product manufacturing activities.
• Work with service departments to develop components that best suit their needs and requirements, enabling this department to supply components in a more suitable way, to improve the overall process flow at Alexion.
• Excellent working knowledge of SAP and BOM’s for an operational viewpoint.
• Manage assigned Vault Quality System tasks in a timely manner.
• Manufacture to a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business.
• Support Regulatory licensure activities, including agency inspections.
• Manage project groups to pull together a functional design working with various departments, coordinating the activities to finalise the component design.
• Be part of project teams from the start where components are being proposed, to ensure at the earliest stage the best components are designed for use by the packaging department (new packing lines and/or new equipment development, etc.) with future upscaling of lines/equipment in mind.
• Communicate operational status regularly to plant management, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
• Support implementation of capital projects within budgets and timelines for component design and use as required.
• Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
• Ad hoc projects and responsibilities as required to meet our commitments to uninterrupted patient supply

You will need to have:

• Third level qualification in a scientific or engineering discipline or equivalent would be desirable.
• A minimum of 5 years’ experience with licensed products and facilities with responsibility for labeling and packaging operations required, with full in-depth understanding of secondary packaging processes and equipment and how they function.
• Understanding of secondary packaging component functions and usage for end users.
• Demonstrated ability to organize and lead manufacturing operations trials and experiments.
• Demonstrated ability to manage both tactically and strategically, to prepare contingency plans and ensure execution of plans through effective organizational delegation.

We would prefer for you to have:

• Experience in new line/product/device start-up desirable.

Date Posted

Closing Date