What are the responsibilities and job description for the Packaging Validation Engineer position at Katalyst CRO?
Summary
- 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.
- 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
- Recent 4-6 years' experience in Packaging Validation activities Hands on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing.
- Hands-on experience in Process validation (IQ, OQ & PQ) activities