Process Engineer Location: WaterfordShift: Days role FTCAbout the Opportunity We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.The Process Engineer works in the MSAT/Technical Services department as a technical leader providing support to technology transfers and Commercial Operations at the Waterford Facility and within the network.Key Responsibilities:Provide leadership and support to operations teams to ensure appropriate standards are metDevelopment and implementation of improvement initiatives in all manufacturing and development operationsLiaise 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 teamsImplementation 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 improvementAbility to multi task and prioritize workloadMaintain required quality documents in a current compliant stateSubject 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 programmes Technical 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 requiredComplaints, LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA's and on time closureAttainment of SMART goals.Reduction in process cycle-timesEnsure compliance to cGMP at all timesAbout YouDegree in Chemical, Industrial or equivalent Engineering disciplineAdvanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantageExperience2 years + experience within Pharmaceutical Development and Manufacturing environmentOEE/SMED/RCA/CI experienceTechnical 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 – StatisticalPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our ALL IN video and check out our Diversity Equity and Inclusion actions