Job Description

The successful candidate will be responsible for providing technical and/or engineering support for Finished Product (FP) packaging development, providing packaging engineering support through all phases of the commercial finished product lifecycle, including packaging materials selection and qualification, technology transfer, validation, and routine FP commercial packing. This involves providing technical support to internal packing as well as packing operations at contract manufacturing organisations (CMOs) used as Alexion pack sites. The position requires effective cross-functional collaboration with external contractors and packaging vendors, as well as internal partners including internal FP subject matter experts, New Product Introduction (NPI), Artwork, Internal/External Manufacturing Operations, Quality, Marketing and Regulatory partners.
You will be responsible for:
• Providing technical support to biologics, small molecule and combination medical device product packaging development at CMOs.
• Support troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners.
• Ownership and management of Packaging Technical Profile Drawings, Change Controls and Risk Assessments executed in support of Packaging Development activities.
• Technical writing of Packaging Tech Transfer Protocols, Packaging Technical Studies and User Requirements Specifications as applied to Packaging Tech Transfers and Launches.
• Collection, organisation, trending, and analysis of Packaging Development data.
• Provide input and other technical documents for regulatory agency submission in support of FP manufacturing processes at internal/external FP manufacturing sites.


You will need to have:
• Bachelors degree in engineering preferred (or similar technical qualification / equivalent experience in pharma or medical device packaging development).
• Experience specifying and qualifying primary and secondary packaging materials.
• Experience developing technical profile drawings for the building of accurate packaging artwork.
• Understanding of cGMP requirements for biopharmaceutical manufacturing.
• Strong communication ability to present and influence.
• Organized analytical thinker with strong attention to detail.
• Excellent oral and written communication skills, including technical writing.
• MS Excel, MS Word, MS Powerpoint proficiency
• Experience of using systems within a GMP environment such as Change Control and Document Management systems.
We would prefer for you to have:
• Exposure to Project Management principles and tools.
• Experience of MS Project or other project management software.
• Exposure/experience of Risk Assessment in a cGMP environment.