Packaging Engineering Specialist in Helwith Bridge - CV-Library

Team Horizon is seeking a Packaging Engineering Specialist (initial 12-month contract) for our client who are a global leader in the biopharmaceutical industry, for their site in Dublin. The successful candidate will be responsible for providing technical and/or engineering support for Finished Product (FP) manufacturing, providing packaging engineering support through all phases of the commercial finished product lifecycle, including technology transfer, validation, and routine FP commercial manufacturing.

Why you should apply:

* Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

* You enjoy working on exciting projects and want to work with a global manufacturing site in Dublin.

What you will be doing:

* 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 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.

* Effective cross-functional collaboration with external contractors and internal partners including internal FP subject matter experts, New Product Introduction (NPI), Internal/External Manufacturing Operations, Quality, Marketing and Regulatory partners.

* Any other duties as assigned.

What you need to apply:

* Bachelors degree in engineering preferred (or similar technical qualification / equivalent experience in pharma or medical device packaging development).

* 5 years experience in packaging.

* 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.

* 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