Packaging Validation Engineer

TechDigital Group; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading tech company is seeking a Packaging Validation Engineer in Bloomington, Indiana. The ideal candidate will have 4-6 years of experience in packaging validation, including hands-on experience in integrity and transit testing. Responsibilities include preparing verification protocols, supporting complaint investigations, and ensuring compliance with ISO and FDA standards. Strong documentation and communication skills are essential for this role, which collaborates closely with various engineering and regulatory teams.

Qualifications

• 4-6 years of experience in Packaging Validation activities.
• Hands on experience in packaging integrity, shelf life, and transit testing.
• Knowledge in FDA regulations and ISO standards.

Responsibilities

• Prepare packaging verification protocols and reports.
• Lead or support complaint investigations related to packaging.
• Collaborate with QA, Engineering, Manufacturing, and Regulatory teams.

Skills

Packaging Validation

Documentation Practices

Communication Skills

ISO 13485 Knowledge

Agile Process

Job 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