Packaging Validation Engineer

Packaging Validation Engineer – Katalyst CRO

Location:

Bloomington, IN

Salary Range: $65,000.00 – $75,000.00

Reports to:

Quality Engineering Manager or QA Manager

• 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.
• Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements.
• Lead or support complaint investigations and resolution related to packaging.
• Support engineering in product validation, risk assessments, product/process development, and change management.
• Lead continuous improvement activities through leadership, facilitation, and collaboration.
• Support packaging integrity, shelf life, and transit testing as part of packaging validation activities.
• Hands‑on experience in process validation (IQ, OQ & PQ) activities and engineering change order creation in Agile.

• Good verbal and oral communication skills.
• Good documentation practice skills.
• Knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Recent 4-6 years’ experience in Packaging Validation activities.
• Hands‑on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing.
• Experience with process validation (IQ, OQ & PQ) activities.

Associate

Contract

Pharmaceutical Manufacturing