Packaging Validation Engineer

Excelon Solutions; Bloomington (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

A medical equipment manufacturing company is seeking a Packaging Validation Engineer for a 12+ month contract in Bloomington, IN. This mid-senior level role involves supporting packaging validation activities including integrity and transit testing, and ensuring compliance with regulatory requirements. Candidates should have recent experience in packaging validation and familiarity with ISO standards. Strong communication skills and the ability to collaborate across teams are essential for this position.

Qualifications

• 4-6 years of experience in Packaging Validation activities.
• Hands-on experience in packaging integrity and transit testing.
• Good verbal and oral communication skills.

Responsibilities

• Prepare packaging verification protocols in compliance with requirements.
• Lead or support complaint investigations related to packaging.
• Collaborate with QA and Engineering to ensure compliance.

Skills

Packaging Validation

Process Validation

Communication Skills

ISO 13485

ISO 14971

FDA 21 CFR 820

Tools

Agile

Job description

Position Name: Packaging Validation Engineer

Location: Bloomington, IN - Onsite

Duration: 12+ months

JD:

• 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 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.

Thanks and Regards,

T: +1.972.694.8486

E: [e-mail]

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Medical Equipment Manufacturing