Packaging Engineering Specialist

Summary:

Packaging Development Engineer

12 Month Contract

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.

Responsibilities:

· 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.

Requirements:

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

· Understanding of cGMP requirements for biopharmaceutical manufacturing.

· MS Excel, MS Word, MS Powerpoint proficiency

· Experience of using systems within a GMP environment such as Change Control and Document Management systems.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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