Ecocareers · 16 hours ago
Packaging Validation Engineer
Bloomington, IN
Full-time
Onsite
Mid, Senior Level
4+ years expConfidential company is seeking a Packaging Validation Engineer to prepare packaging verification protocols and reports in compliance with regulatory and internal requirements. The role involves leading and supporting complaint investigations related to packaging and ensuring proper documentation of validation activities.
Staffing & Recruiting
Responsibilities
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
Qualification
Required
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
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
Recent 4-6 years' experience in Packaging Validation activities
Hands on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing
Mandatory: Medical Device Industry
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase