Sr Associate Tech Engineering

Career Category

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.