Validation Engineer Equipment

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Validation Engineer Equipment - Puurs

We are looking for a Validation Engineer Equipment with experience in equipment within a pharmaceutical production environment for a project for our client in Puurs.

Your responsibilities as a Validation Engineer Equipment

  • Coordination of validation and planning activities

    • Supports the project lead in coordinating the project team to achieve the defined project time line.

      • 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.

  • Management of Projects

    • Responsible for initiation, planning and execution of engineering projects related to Quality Systems (Validation, CRF, MIR, CAPA, …).

    • Responsible for initiation, planning and execution of projects related to Engineering Systems (Technology Management, Project Management, Good Engineering Practices, Testing and Contractor Management).

    • Responsible for initiation, planning and execution of projects related to Engineering Systems (Technology Management, Project Management, Good Engineering Practices, Testing and Contractor Management).

  • Process Ownership

    • Acts as engineering representative in Process Teams related to Quality Systems (change management, verification, validation, …).

    • Acts as SME and SPOC for scheduling and MS projects in the engineering department.

    • Acts as back-up for the Process Owner Verification.

What do we expect from a Validation Engineer Equipment

  • Education - Master in Engineering.

  • Experience - Experience with equipment and a pharmaceutical production environment. Experience in validation is nice to have.

  • Knowledge - Good knowledge of Dutch and English.

  • Skills - Project management, planning & coordination skills.

Why choose Enginity?

Enginity NV is a young, and fast growing company within the Cronos Group. We focus on Engineering, Innovation and improvement projects related to industry 4.0. We work as a strategic partner for our customers in industry and manufacturing to complete their project team. Our engineers shape and transform projects to their benefit.

Within Enginity you will have the opportunity to participate in challenging projects and will be guided on the basis of a personal development plan. In addition, we will look at training sessions together to refine your soft and hard skills. In addition, we offer an open-ended contract based on a gross salary supplemented by a number of extra-legal benefits and a company car, including a fuel card.

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