Role and ContextPositionProcess EngineerReporting PositionReporting to applicable Manager/Team Leader of the areaWorking RelationshipSupporting Manufacturing areas and all support departmentsKey Internal Contacts: Manufacturing, QA, QC, Validation, Regulatory, EHS, Program Management and FinanceKey External Contacts: Equipment vendors, component suppliers, other Genzyme sites, Development pharmaceutics groups and benchmarking organisationsPurpose of RoleProvide leadership and support to operations teams to ensure appropriate standards are metDevelopment and implementation of improvement initiatives in all manufacturing and development operationsNeed to DoJob RequirementsLiaise 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 requiredCompliance Related TasksComplaints, LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA's and on time closureAttainment of SMART goals.Reduction in process cycle-times.Ensure compliance to cGMP at all timesNeed to KnowQualificationsDegree 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 experience.Skills and KnowledgeTechnical 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 - StatisticalDesignation DutyMay be required to deputise for Team Leader / Manager if requiredPersonal CharacteristicsCreative and innovative approachAbility to interact effectively in multi-disciplinary teamsStrong team player ("Owl" characteristics)Seeing tasks through to successful completionExcellent communicator