Sr. Engineer Process Development

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.

Key Responsibilities

• 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.

Basic Qualifications

• 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.

Preferred Qualifications

• 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.