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Validation Engineer

    Validation Engineer - County Longford, Ireland - Cpl

    Cpl
    Cpl County Longford, Ireland

    Found in: beBee S2 IE - 2 days ago

    CPL background
    Full time
    Description

    Our client - a rapidly expanding medical device manufacturing facility in Longford requires a Validation Engineer . This is a unique opportunity to build your career with a global leader in its field. Will support the successful qualification of new tools / product introduction on-site. Permanent role with benefits. If interested, do email an updated word copy of your CV or give me a call on

    Role

    · Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge.

    · Developing and implementing solutions to sustain and improve the QMS.

    · Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.

    · Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.

    · Generation of risk assessments, covering cleaning, validation, and process.

    · Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.

    · Directly supports GMP and regulatory audits.

    · Prepare and deliver training modules as required.

    · Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis

    · Support continuous improvement through Lean Six Sigma methodologies.

    · Execution/ development of change controls.

    · Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc.;

    · Implement subsequent corrective action through the change management system.

    · Participate/ lead cross functional teams including liaising with vendors on projects.

    Requirements

    · Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.

    · Experience in statistical analysis (Minitab) / SPC / validations.

    · Excellent interpersonal, communication, influencing, and facilitation skills

    · Experience as a Validation Engineer within an Injection moulding or medical manufacturing environment preferred.

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