Package Validation
Package Validation is a crucial process in medical device manufacturing where companies ensure that the packaging used to protect medical devices remains safe and intact throughout storage and shipping. Think of it like making sure a protective container will keep medical equipment sterile and undamaged from the factory until it reaches the hospital or clinic. This process involves testing packages under different conditions like temperature changes, humidity, and rough handling to make sure they meet safety standards. This term might also appear as "packaging validation" or "sterile barrier validation" in job descriptions.
Examples in Resumes
Led Package Validation projects for Class II medical devices, ensuring compliance with FDA requirements
Conducted Package Validation and Packaging Validation studies for sterile medical products
Managed Sterile Barrier Validation protocols and testing for surgical instruments
Typical job title: "Package Validation Engineers"
Also try searching for:
Where to Find Package Validation Engineers
Professional Organizations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you handle a failed package validation test?
Expected Answer: A senior candidate should explain the process of investigating root causes, documenting findings, implementing corrective actions, and re-validating the package. They should mention involving quality assurance and possibly regulatory affairs teams.
Q: What factors do you consider when developing a package validation protocol?
Expected Answer: Should discuss considering shipping conditions, storage environment, shelf life requirements, sterilization methods, and regulatory requirements. Should mention risk assessment and test method selection.
Mid Level Questions
Q: What are the main types of package testing you're familiar with?
Expected Answer: Should mention visual inspection, seal strength testing, drop testing, and environmental conditioning. Should be able to explain why each type is important.
Q: How do you determine appropriate sample sizes for package validation?
Expected Answer: Should discuss statistical considerations, regulatory requirements, and risk levels. Should mention consulting standards and guidelines for minimum sample sizes.
Junior Level Questions
Q: What documentation is required for package validation?
Expected Answer: Should mention test protocols, results reports, photos of samples, data collection forms, and summary reports. Basic understanding of documentation requirements.
Q: What are the basic requirements for medical device packaging?
Expected Answer: Should discuss maintaining sterility, protecting the product, proper labeling, and ease of use in medical settings. Basic understanding of package purposes.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of testing procedures
- Knowledge of documentation requirements
- Familiarity with quality control basics
- Understanding of sterile barrier systems
Mid (2-5 years)
- Test protocol development
- Project management
- Understanding of regulatory requirements
- Experience with different testing methods
Senior (5+ years)
- Risk assessment and mitigation
- Validation master planning
- Team leadership
- Regulatory compliance expertise
Red Flags to Watch For
- No knowledge of FDA or ISO requirements for medical packaging
- Lack of experience with documentation practices
- No understanding of sterilization methods
- Unfamiliarity with testing equipment and procedures
Related Terms
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