Sr. Engineer Process Development Job at Amgen (Dun Laoghaire)

Job Description

The Senior Engineer, Process Development will provide process development support for the Optima syringe filling lines at Amgen Dun Laoghaire (ADL). The role will support key expansion activities, including filling characterisation, qualification of filling technology and the introduction of new single-use technology for two new syringe filling lines. As part of the Process Development (PD) organization, the Senior Engineer will provide technical support for large molecule and small molecule drug product manufacturing at ADL. The role partners closely with Manufacturing, Operations, Engineering, Quality, Validation, external vendors and network teams to deliver robust, compliant and data-driven manufacturing support.

Job Responsibility

Provide filling characterisation support, including filling recipe development, protocol development, protocol execution, data analysis and technical reporting
Apply process development expertise to sterile drug product processing, including process characterisation, filling operations and single-use systems (SUS)
Support commercial drug product manufacturing through technical evaluation of nonconformances (NCs), corrective and preventive actions (CAPAs), deviations/exceptions and technology transfer activities
Troubleshoot drug product processing technologies and equipment, using data-driven analysis and visualisation to determine root cause and recommend effective corrective actions
Lead or support deviation/exception resolution, root cause analysis, risk assessments and CAPA development/implementation for drug product operations
Lead and contribute to cross-functional and cross-site teams, providing technical recommendations to management and helping advance complex projects to completion
Partner with Manufacturing, Operations, Engineering, Quality, Validation, external vendors and other support functions to provide coordinated technical support to manufacturing
Ensure site activities meet safety expectations, customer quality requirements and applicable regulatory expectations, including FDA, EU and other international standards
Review and approve process validation protocols, assessments and quality system documentation, as required
Contribute to product quality assessments, process flow documentation and validation strategies
Support the introduction or modification of equipment and single-use systems that may impact validated processes, in collaboration with site and network teams

Requirements

Bachelor's degree in Science, Engineering, Quality or a related discipline and 5 years of directly related experience
OR Master's degree and 3 years of directly related experience
OR Associate's degree and 10 years of directly related experience
Knowledge of cGMP and applicable global regulatory requirements
Strong understanding of aseptic manufacturing technologies and cGMP expectations
Ability to apply engineering and scientific principles to formulation, single-use systems and filling process design and implementation
Demonstrated problem-solving skills with strong written, verbal and technical communication skills
Ability to work effectively in cross-functional teams in a highly regulated manufacturing environment

Nice to have

PhD or Master's degree in Science or Engineering
5+ years of experience supporting commercial protein drug product processing in areas such as sterile processing, process characterisation, technology transfer and/or validation
Experience with drug product filling technologies, including peristaltic pumping

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Sr. Engineer Process Development

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