Job Description
This position is for a Sr Associate Tech Engineering **,** to join the Process Development Commercial Support team based in Amgen Dun Laoghaire (ADL). The team is responsible for providing process and product support to drug product formulation and fill-finish operations in ADL as drug product process SMEs.
**Core responsibilities will include:**
+ Day-to-day operations support in sterile drug product unit operations such as formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
+ Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.
+ Acting as a subject matter expert during change controls, assessing the impact of proposed changes on the product and process performance.
+ Supporting new product introductions (NPI), including recipe and protocol development, batch execution support and troubleshooting.
**Core responsibilities will include:**
+ Day-to-day operations support in sterile drug product unit operations such as formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
+ Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.
+ Acting as a subject matter expert during change controls, assessing the impact of proposed changes on the product and process performance.
+ Supporting new product introductions (NPI), including recipe and protocol development, batch execution support and troubleshooting.
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