The Project Validation Coordinator is member of the Engineering Quality & Systems team and supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation.Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management and inspectorsContinuously follows up the predefined validation strategy, adjusts and/or escalates if needed and provides overview of the status and potential impact on project timelineCoaches the project engineers related to validation and quality systems and watches over good validation practices and the quality of the different deliverablesFacilitates and documents quality system risk assessment activitiesProvides input for management communication & reportingBridges between Engineering, Quality Projects, STS/LA, SME’s and System OwnersFunctions as subteamlead Validation within the project team charterSupports the project lead in coordinating the project team to achieve the defined project time lineComposes, consolidates and maintains the general project schedule file to keep the overview of all milestones towards the completion of the projectMonitors continuously this overall project schedule file and keeps the project team informed regarding the progress and alerts problems/conflicts relating to the execution of project tasks and interrelations of project activitiesAssists the project lead to define and evaluate planning risks and mitigation planProvides input for management communication & reportingProfileA Master degree in a Scientific discipline (Engineering, Bio-engineering, Pharmacy, …)Minimum of 3 years of experience in the pharmaceutical industryKnowledge of ValidationKnowledge of Quality Management SystemsKnowledge of RegulatoryKnowledge and experience as audit spokes personSpecific training and skillsStrong organizational skills and structured approachHigh level of social and communication skillsFluent in Dutch and English