CQ SME Senior Engineer

Job SummaryThe scope of CQ activities relates to Fill Finish and Process Support Equipment, where schedule allows.The CQ FF SME is responsible for coordinating CQ related activities including supporting Documentation Preparation, FAT, Installation, Hook Up, MC Oversight, active CQ Execution involving Safe / LOTO Team, Various Vendors, Calibration Group, Automation, CQV Team and USER – Ops and QA Team.Main ResponsibilitiesGeneral Management and CoordinationMeeting and delivering key project milestonesImplementation of CORP-35 and supporting guidelinesAdherence to EU Annex 15Actively Support CQ Documentation (FRAs, DQs, Gap Assessment, Lonza Commissioning, IQs and OQs)CQ Execution Readiness (Permits, Availability of Materials and Consumables, Tooling, Calibrations, Utilities, Ops support, Automation support and CQV support)Hands On CQ Execution (Vendor Oversight, Execution of Commissioning Protocols, IQ and OQ Test Plans)Participate in MC, P+ID Walk down and Punch item CategorisationDeviation/Incident Management & Change Control (Process)Punch List ManagementVendor Management & Management of Third Party SupportReviewing CQ test plans and specifications prior to their approvals and post executionManagement and Filing of CQV related documentationSystem and Area HandoverMain Responsibilities and Tasks Relating to CQV Documentation:Coordinating development and approvals with the Client, Construction QA lead, and with other disciplines including Vendors, Automation, E+I, and USER etc.Developing positive working relationships with team members and USER groupsEnsuring adherence to schedule, manhours and qualityReview and approval of VTOD and CTODGeneration (Kneat digital platform) & execution of commissioning & qualification protocolsActively support Doc Prep team within the Kneat SystemsRisk Assessments, GAP Analysis, DQ ExecutionReview of Vendor Docs incl FAT and SAT, IQ and OQsDevelopment of Lonza CTPs, IQ and OQExecution Readiness:FAT support where requestedDocumented training on PSPsCQ Team development and resource allocationMonitoring and coordinating MC readinessCQV documentation readinessMonitoring and coordinating Automation readinessMonitor and coordinate SUT installationAppointment of Sub ContractsCalibration readiness including test equipment and resourcingHSE Plans, System PSSRs and LOTOTO 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 establishedHSE management in conjunction with HSE LeadMC acceptanceCoordinate CQV execution activities in conjunction with Vendors and Lonza Automation GroupExecution of commissioning test protocols, IQ and OQVendor Management during SAT (Scheduling, Arrival On site, HSE Induction, SAT, IQ and OQ Oversight, Training, Handover)Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, VTOD, CTOD and SAT)Tracking of changes, punch items and deficienciesReviewing first of type CQ test reports prior to their approvalsAssisting system leads/engineers with system handover to productionPQ and PPQ support where necessaryProject Controls:Planning & SchedulingSupport with overall System based baseline CQV Schedule in conjunction with Engineering, CM and USER Group involving;System Definition & System ClassificationMC alignment with ConstructionHandover alignment with USERFortnightly updates to CQ schedule including actualized and forecasting data for Doc Prep and Execution PhasesInput to monthly project report including but not limited to:Progress Reporting & Progress measurementScope changesRisks, Challenges and MitigationsKey Performance Indicators:Strong knowledge and experience of Process Commissioning and Qualification Fill Finish and Process Support EquipmentManagement: Compliance with a schedule at a system and area level with the planned resource levels.Positive Feedback from Customer (i.e. Quality, HSE, operations)Safety: No lost time accident and Focus on Start Up SafetyEquipment Functionality: Robust and Repeatable Commissioning with no spurious alarms in line with URS, Technical and Functional specs. Well-executed Kneat Test protocols with minimum rework, deviations and re-executionQuality: Compliance with GDP, all deviations resolved to Client satisfaction and handover completed for all systems.Project Controls: Support with scheduling, punch item management, reporting and progress measurement #J-18808-Ljbffr