Process Engineer Scientist

5 days ago

Dublin, Ireland Arcadis DPS Full time

We are seeking a Process Engineer / Scientist to join the Process Development Commercial Support team. This team is responsible for providing process and product support to drug product formulation and fill-finish operations, acting as subject matter experts (SMEs) for all drug product processes. The successful candidate will provide technical and process support, lead investigations, and drive continuous improvement initiatives to optimise performance and ensure robust operations within a GMP environment. Key Responsibilities Primary Focus Areas: Provide day-to-day operational support as a subject matter expert indrug product formulation, vial filling, pre-filled syringe filling, lyophilization, and vial capping. Serve as a key contributor toproduct and process investigations, including assessment of product and process impact. Leadcontinuous improvement projects aimed at enhancing process performance, yield, and productivity. Additional Responsibilities Include: Assess product impact associated with proposed process changes under the change control system. Generate product impact assessments for process deviations and excursions, referencing relevant product technical documentation. Supportnew product introductions (NPI) as a process SME including recipe development, protocol execution, troubleshooting, and investigation support. Review and approve updates to operating procedures, electronic batch records, and product documentation. Conductrisk assessments and implement mitigation strategies related to equipment and line performance. Performprocess gap analyses and develop strategies to address identified issues. Analyseprocess performance data and trends to identify and resolve potential issues. Basic Qualifications Bachelors or Masters degree inEngineering, Science, or a related discipline, with a minimum of6 years experience in a similar role;OR PhD with3 years of directly related experience. Preferred Qualifications 46 years experience indrug product formulation, vial or pre-filled syringe filling, or lyophilisation. Experience withnew product introductions (NPI), process development, or MSAT in aGMP environment. Certification or demonstrated experience inLean orSix Sigma methodologies. Strong analytical, problem-solving, and communication skills. Skills: Syring NPI Management Science Process Engineer Process Engineer Scientist Formulation Filling Benefits: Parking

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