Project Engineer Quality & Systems

작업 내용

• coordination of validation & planning activities in capital projects
• scheduling capital project activitiesprojects related to Quality Systems and Engineering Systems
• point of contact validation coordination and planning

• Degree
• Master degree
• Formal education
• Scientific discipline (Engineering, Bio-engineering, Pharmacy, …)
• Experience required
• Minimum of 3 years of experience in the pharmaceutical industry
• Knowledge of and experience in Validation
• Knowledge of and experience in Scheduling and MS Project
• Knowledge of and experience in Quality Management Systems
• Experience with at least one other Engineering System: Technology Management, Project Management, Good Engineering Practices, Testing and/or Contractor Management.
• Specific training and skills
• Strong organizational skills and structured approach
• High level of social, communication and coaching skills
• Capable to maintain a good overview while diving into details when needed
• Knowledge of PC applications Word – Excel – Powerpoint – Sharepoint – MS Projects
• Fluent in Dutch and English

• 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 inspectors.
• Continuously follows up the predefined validation strategy, adjusts and/or escalates if needed and provides overview of the status and potential impact on project timeline.
• Coaches the project engineers related to validation and quality systems and watches over good validation practices and the quality of the different deliverables.
• Facilitates and documents quality risk assessment activities.
• Provides input for management communication & reporting.
• Bridges between Engineering, Site Compliance, SME’s and System Owners.

• Supports the project lead in coordinating the project team to achieve the defined project time line.
• Composes, consolidates and maintains the project schedule file in MS Project.
• Monitors continuously the project schedule file and keeps the project team informed regarding the progress and alerts problems/conflicts relating to the execution of project tasks and activities.
• Assists the project lead to define, evaluate and document project risks and mitigation plan.
• Provides input for management communication & reporting.

• Supporting role in the audit preparation of planned inspections
• Communication
• Preparation of the inspection tour (focus on construction zones and Engineering projects)
• Follow-up construction area audit readiness
• Follow up availability engineering spokes persons
• Preparation pre requests inspections
• Post audit support
• Support/coordination in defining audit responses and action plans
• Acts as back-up for the owner of the audit readiness program in engineering

• Responsible for the initiation, planning and execution of projects related to Quality Systems (Systems Validation, CRF, MIR, CAPA, …).
• Responsible for the initiation, planning and execution of projects related to Engineering Systems (Technology Management, Good Engineering Practices, Testing and Contractor Management).
• Acts as Engineering representative in process teams related to Quality Systems (change management, verification, validation, …).
• Investigation, documentation and follow-up of deviations (MIR) related to engineering projects
• Acts as back-up for the process owner Systems Validation.