Packaging Development Engineer
Are you looking for the chance to be part of a life-changing pharmaceutical organisation's mission to continuously drive innovation? We are recruiting for a Packaging Development Engineer
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation paves the way with state-of-the-art technology on their one-of-a-kind manufacturing facility.
Responsibilities:
* Providing technical support to biologics, small molecule, and combination medical device product packaging development at Contract Manufacturing Organisations (CMOs).
* Supporting 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.
* Providing input and other technical documents for regulatory agency submission in support of Finished Product (FP) manufacturing processes at internal/external FP manufacturing sites.
Requirements:
* Bachelor's degree in engineering preferred (or similar technical qualification/equivalent experience in pharma or medical device packaging development).
* Understanding of Current Good Manufacturing Practice (cGMP) requirements for biopharmaceutical manufacturing.
* Strong communication ability to present and influence.
* Analytical thinker with strong attention to detail.
* Excellent oral and written communication skills, including technical writing.
* Microsoft Excel, Microsoft Word, Microsoft PowerPoint proficiency.
* Experience of using systems within a Good Manufacturing Practice (GMP) environment, such as Change Control and Document Management systems.