Job SummaryThe CQ Engineer is responsible to support Doc PREP and Execution as it relates to CM oversight, MC acceptance, CQ execution and successful handover to the Client USER team.The scope of CQ activities will relate to Utilities. The CQ Engineer will report to the CQ Area Owner.In line with PDP and Client C+Q requirements, the CQ Engineer will ensure adherence to the Baseline Schedule, Functional, Technical and GDP Compliance and adherence to Start Up safety procedures in line with best practices and Project expectations.Main ResponsibilitiesGeneral Management and Coordination in conjunction with Client and PDP Team :Maintenance of training material and recordsImplementation of CORP-35 and supporting guidelinesCQ Doc Preparation via KNEATHSE and Safe Start-Up including PTW and LOTOCQV Execution ReadinessCQV Execution via KNEATMC, P+ID Walk down and Punch item CategorisationDeviation Management & Change Control (Process and Automation)Punch List ManagementVendor ManagementSystem and Area HandoverExecution Readiness:FAT coordination as requestedDocumented training on PSP'sCQ Team development and resource and allocationMonitoring and coordinate MC readinessCQV documentation readinessMonitoring and coordinate Automation readinessMonitor and coordinate SUT installation in conjunction with OPS/BPE'sCalibration readiness including test equipment and resourcingHSE Plans, System PSSR's and LOTO device readinessVendor notification of SAT dates per CQ ScheduleMaterials, consumables, spares, first fill available in storesEnsuring the fulfilment of the general pre-requisites, needed to start with CQV executionCQV Execution:Ensure daily multidisciplinary CQV, Eng, CM and USER coordination meetings are establishedAdherence to Client LOTOTO and PTW SystemsMC acceptanceCQ Execution (incl Coordination of E,I and C, Calibrations and Vendors)Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, CTOD and SAT)Tracking of changes, punch items and deficienciesAssisting system leads/engineers with system handover to productionClean UtilitiesWFI Generation SystemsWFI Storage TanksWFI DistributionClean Steam GeneratorsClean Steam DistributionO2/ CO2/ N2 DistributionCompressed Air (Oil Free) DistributionBlack UtilitiesPlant Steam SupplyPlant Steam CondensateProcess DrainsProcess VentsProcess Waste Lift StationChemical Waste Lift StationProtected (Potable) Fresh WaterSafety Shower WaterUtility WaterInstrument AirChilled Water (Supply/Return)Sanitary Waste & VentsChemical Drains and VentsAC Collection WasteFire Water DrainageReference AirProject Controls:Attend regular coordination meetingsLiaise with CQ Area Owners w.r.t Plan and Progress UpdatesKey Performance IndicatorsStrong knowledge and experience of Process Commissioning and Qualification.Management: Compliance with a schedule at a system and area level with the planned resource levels.Feedback from customer (i.e. Quality, HSE, operations)Safety: No lost time accidentQuality: well-executed testing with minimum rework and re-execution.Quality: all deviations resolved to Client satisfaction and handover completed for all systems.Ideal BackgroundEducation (minimum/desirable): Minimum BS in Engineering or Facility Management - preferably in Chemical, Mechanical, Facility, Industrial, Quality or Pharmaceutical Engineering.Languages: English - fluent in speaking and writing.Experience: Minimum 5 yrs. plus of Biotech or Pharmaceutical cGMP experience is required.Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.Has successfully defended systems before FDA, EMA etc. inspections.CQV documentation experience Using KNEAT Software an advantage