4-6 years of recent experience in Packaging Validation
Strong knowledge of Good Documentation Practices
Good verbal and written communication skills
Working knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820
Experience in a regulated manufacturing environment
Responsibilities
Perform hands-on packaging validation activities including testing for packaging integrity, shelf-life, and transit.
Prepare validation protocols and reports per regulatory and internal standards.
Execute Process Validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Lead or support investigations of complaints related to packaging issues.
Support engineering in product validation, risk assessments, and process development.
Facilitate continuous improvement activities through collaboration and leadership.
Document and control all packaging validation activities accurately.
Coordinate with various teams including QA, Engineering, Manufacturing, Regulatory, and Supply Chain to ensure compliance and communication.
Benefits
Collaborative work environment with cross-functional team interactions
Opportunity to lead continuous improvement initiatives
Engagement in hands-on validation activities
Involvement in regulatory compliance processes
Support in professional development and training opportunities
Full Job Description
Job Summary:
The Packaging Validation Engineer will be responsible for supporting and executing packaging validation activities to ensure packaging integrity, compliance, and product quality.
This role works closely with Quality, Engineering, Manufacturing, and Regulatory teams and supports validation, change management, and continuous improvement initiatives in an onsite manufacturing environment.
Roles & Responsibilities:
Perform hands-on packaging validation activities, including packaging integrity, shelf-life, and transit testing
Prepare packaging verification/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 resolutions related to packaging
Support engineering with product validation, risk assessments, product/process development, and change management
Support and lead continuous improvement activities through collaboration and facilitation
Ensure all packaging validation activities are properly documented and controlled
Collaborate with QA, Engineering, Manufacturing, Regulatory, and Supply Chain teams to ensure compliance
Communicate packaging validation status and issues effectively across departments
Create and manage Engineering Change Orders (ECOs) using Agile
Experience:
4-6 years of recent experience in Packaging Validation
Strong knowledge of Good Documentation Practices
Good verbal and written communication skills
Working knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820
Experience working in a regulated manufacturing environment
