Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Summary:
- The Packaging Validation Engineer is responsible for executing and supporting packaging validation activities to ensure packaging systems meet regulatory, quality, and internal requirements.
- The role involves hands-on validation, documentation, cross-functional collaboration, and compliance with FDA and ISO standards.
- The position works closely with Quality, Engineering, Manufacturing, and Supply Chain teams and typically reports to the Quality Engineering Manager or QA Manager.
Roles & Responsibilities:
- Perform hands-on packaging validation activities including packaging integrity, shelf-life, and transit testing.
- Prepare packaging verification and validation protocols and reports in compliance with regulatory and internal requirements.
- Execute and support process validation activities including IQ, OQ, and PQ.
- Lead or support complaint investigations and resolution related to packaging.
- Support engineering activities related to 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, controlled, and compliant with Good Documentation Practices.
- 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.
- Support engineering change order (ECO) creation in Agile environments.
Experience:
- 4–6 years of recent experience in packaging validation activities.
- Hands-on experience with packaging integrity, shelf-life, and transit testing.
- Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820.
- Experience with process validation activities (IQ, OQ, PQ).
- Strong documentation, verbal, and written communication skills.