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Process engineer

Waterford
Prochem Engineering
Process engineer
Posted: 11 December
Offer description

Role Summary:Provide leadership and support to operations teams to ensure appropriate standards are met.Development and implementation of improvement initiatives in all manufacturing and development operationsCore Duties and 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 metricsLead 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.Ability to multi task and prioritize workload.Maintain required quality documents in a current compliant state.Subject Matter Expert for and team resource for new product introductions / enhancement development projectsResource for Clinical supply provision projectsAseptic manufacture or oral dose manufacture contextSubject Matter Expert for product quality attributes and process critical parametersDesign 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 activitiesProcess/product deviation investigation and resolutionTechnical report writingTraining delivery of technical training programmesSupport of process qualification and process validation activities as requiredMinimum Qualifications and 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(theory and practice) of aseptic manufacturing including lyophilisation considered an advantageDesign of Experiment and associated statistical techniquesPharmaceutical product development project life-cycleStrong report-writing and verbal communication skillsLaboratory and pilot plant skillsResearch skillsInnovation and creativity skillsProject management skillsStructured Problem-solving skills – Statistical

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