CQV Engineer - The Netherlands - IT-People B.V.

    IT-People B.V.
    IT-People B.V. The Netherlands

    3 dagen geleden

    Beschrijving
    • Excellent salary and benefits package
    • Relocation support
    • Extensive education and training opportunities
    • Exciting (capital) projects
    • Working in an international environment

    The Company

    For a leading global biotechnology company based in The Netherlands I'm looking for an experienced Engineer with solid experience in writing design documentation (URS, FDS, HDS and DS), validation, commissioning and secondary packaging lines.

    The Role

    The Senior Engineer supports manufacturing operations within device assembly, inspection, labeling, and packaging. In this role, you will lead technical equipment projects from concept to implementation and ensure that production equipment performs reliably, safely, and efficiently. You will work closely with cross-functional teams such as production, quality, and maintenance, acting as a technical expert for equipment design, upgrades, and troubleshooting.

    Responsibilities

    • Define project scope and translate user needs into clear technical specifications and design documentation (URS, FDS, HDS, design reviews).
    • Manage technical equipment projects, including planning, prioritization, resource coordination, and stakeholder communication.
    • Oversee installation, testing, validation, and commissioning of new or modified equipment.
    • Support factory and site acceptance testing (FAT/SAT) together with engineering and vendors.
    • Investigate equipment failures, perform root cause analyses, and implement sustainable solutions.
    • Run technical experiments and characterizations to optimize equipment performance and process effectiveness.
    • Collaborate with process, quality, and operations teams on continuous improvement initiatives.
    • Ensure compliance with GMP standards, internal procedures, and safety regulations.
    • Contribute to a safe and compliant working environment at all times.

    Requirements

    • Bachelor's degree or higher in Mechanical, Electrical, Chemical Engineering, or a related technical field.
    • Approximately 5+ years of relevant engineering experience, with several years in a manufacturing or operations environment.
    • Experience in regulated industries such as pharmaceutical, medical devices, or high-tech automated production is strongly preferred.
    • Solid understanding of equipment design, installation, validation, and lifecycle management.
    • Familiarity with GMP and other regulatory frameworks (e.g., OSHA, environmental or safety standards).
    • Strong analytical and problem-solving skills with a structured approach to documentation and project work.
    • Ability to work collaboratively with multiple stakeholders and external suppliers.
    • Willingness to occasionally work outside standard office hours when projects require it.
    • Fluent in English, both written and spoken.
    • Proficient in MS Office and general engineering software tools.

    For more info about this position please contact us on: or upload an updated resume.

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