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
Numbers & Facts
Location
Bloomington, IN
Industry
Other/Not Classified
Company Size
100 to 499 employees
Skills
Agile Programming Methodologiesunmatched
Change Managementunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Engineering Change Orderunmatched
FDA (Food and Drug Administration)unmatched
ISO (International Organization for Standardization)unmatched
Leadershipunmatched
Manufacturingunmatched
Manufacturing Requirementsunmatched
Presentation/Verbal Skillsunmatched
Process Developmentunmatched
Process Validationunmatched
Product Testingunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Regulatory Complianceunmatched
Resolve Customer Issuesunmatched
Risk Analysisunmatched
Supply Chainunmatched
Technical Supportunmatched
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