Packaging Validation Engineer

Packaging Validation Engineer

Position:
Packaging Validation Engineer

Location:

Bloomington, IN
Mandatory:
Medical Device Industry

Base pay range: $35.00/yr - $40.00/yr

• 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.

• Excellent documentation and communication skills.

• Seniority level:
  Executive
• Employment type:
  
  Full-time
• Job function:
  Quality Assurance
• Industry: Software Development