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.
+ Driving continuous improvement initiatives to enhance process capability, reduce variability and improve productivity.
+ Analysing manufacturing data trends to identify opportunities for improvement and prevent potential issues.
+ Reviewing and approving GMP documentation such as SOPs, electronic batch records, and product technical documentation.
+ Risk assessments and mitigation projects relating to filling line performance.
The chosen candidate will work in a collaborative manner within the process team structure and contribute as a member of cross functional teams within the local organization and functional team globally.
**Basic Qualifications:**
+ Bachelor’s, Masters or PhD degree in Science, Engineering or related discipline with 2+ years experience in a similar role.
+ Direct Experience supporting vial/pre-filled syringe filling operations.
**Preferred Qualifications**
+ Thorough knowledge of GMP biotechnology manufacturing, with a significant understanding and knowledge of cGMPs. Experience with regulatory agency audits is beneficial.
+ Strong problem-solving technical skills related to parenteral drug product manufacturing.
**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.
+ Driving continuous improvement initiatives to enhance process capability, reduce variability and improve productivity.
+ Analysing manufacturing data trends to identify opportunities for improvement and prevent potential issues.
+ Reviewing and approving GMP documentation such as SOPs, electronic batch records, and product technical documentation.
+ Risk assessments and mitigation projects relating to filling line performance.
The chosen candidate will work in a collaborative manner within the process team structure and contribute as a member of cross functional teams within the local organization and functional team globally.
**Basic Qualifications:**
+ Bachelor’s, Masters or PhD degree in Science, Engineering or related discipline with 2+ years experience in a similar role.
+ Direct Experience supporting vial/pre-filled syringe filling operations.
**Preferred Qualifications**
+ Thorough knowledge of GMP biotechnology manufacturing, with a significant understanding and knowledge of cGMPs. Experience with regulatory agency audits is beneficial.
+ Strong problem-solving technical skills related to parenteral drug product manufacturing.
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