Summary:Our client is a biopharmaceutical company in Waterford looking for aProcess Engineerwho will support manufacturing and drive development and implementation of improvement initiatives in the fill finish manufacturing and development operations.Responsibilities:Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operationsOptimisation of manufacturing and development operationsIdentification & implementation of opportunities for improvementsAssist in the implementation of capital projectsAct as process lead for inspection developmentLead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.Implementation and monitoring of performance metrics.Lead cycle time reduction initiatives in conjunction with manufacturing teamsImplementation of best practiceProcess development programme design / plant trials, execution and implementationConstantly seeking to challenge operational standards and driving continuous improvement.Maintain required quality documents in a current compliant state.Resource for Clinical supply provision projectsAseptic manufacture or oral dose manufacture contextDesign and execution of experimental programmesOperation of process laboratoriesScale-up and technology transfer project roleLiaison for Clinical supply provision projectsLiaison for new formulation and product enhancement programmesTechnical representative for assessment and development of process change control and regulatory submission proposalsTechnical support and trouble-shooting in support of manufacturing activitiesSupport of process qualification and process validation activities as requiredQualifications & Experience:Degree in Chemical, Industrial or equivalent Engineering disciplineAdvanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage2 years + experience within Pharmaceutical Development and Manufacturing environmentOEE/SMED/RCA/CI experience. Technical knowledge of aseptic manufacturing including lyophilisation considered an advantagePharmaceutical product development project life-cycleStructured Problem-solving skills – Statistical