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Packaging Validation Engineer

TechDigital

  • Bloomington, IN
  • 3 days ago

    Highlights

    The Packaging Validation Engineer typically reports to the Quality Engineering Manager or QA Manager, and works closely with manufacturing, production engineering, and supply chain teams. Hands on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing.

    Numbers & Facts

    LocationBloomington, IN
    IndustryOther/Not Classified
    Company Size100 to 499 employees

    Description

    Mandatory: Medical Device Industry
    • Recent 4-6 years' experience in Packaging Validation activities
    • Hands on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing.
    • Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements.
    • Hands-on experience in Process validation (IQ, OQ & PQ) activities.
    • Lead or support complaint investigations and resolution related to packaging.
    • Support engineering in product validation, risk assessments, product/process development, and change management.
    • Support and lead continuous improvement activities through leadership, facilitation, and collaboration
    • Ensure all packaging validation activities are properly documented and controlled.
    • Collaborate with QA, Engineering, Manufacturing, and Regulatory teams to ensure packaging meets product and compliance requirements.
    • Communicate effectively across departments regarding packaging validation status and issues.
    • The Packaging Validation Engineer typically reports to the Quality Engineering Manager or QA Manager, and works closely with manufacturing, production engineering, and supply chain teams.
    • Good documentation practice skills.
    • Good verbal and oral communication skills
    • Good Knowledge in ISO 13485, ISO 14971, FDA 21 CFR 820.
    • Hands on experience in Engineering change order creation in Agile

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