Packaging Validation Engineer
Bloomington, Indiana, United States
Job Description
Job Summary:
- Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements.
- 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.
- Recent 4-6 years' experience in Packaging Validation activities.
- Hands on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing.
- 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.
- Hands-on experience in Process validation (IQ, OQ & PQ) activities.
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Career Focus: Validation
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