Medical Device Packaging Validation Engineer
Packaging Validation Engineer
Our client is a medical device organization that develops a number of radiology and CT devices. They are currently working on validating a new production line for their devices, and have a robust team of engineers executing a project with multiple facets pertaining to the validation of equipment/devices. Our client wishes to move full time employees back into sustaining roles and supplement the team with an experienced consultant well-versed in packaging validation and ready to hit the ground running.
Scope of Work:
This consultant will be from a Medical Device background, and must have experience validating Packaging Equipment. The consultant will be writing and executing packaging validation protocols (IQ/OQ/PQ), performing process and Test Method validations, process design validations, etc.The client uses a primary packaging process, has a thermoformed packaging process in place and some multipack processes as well.
General responsibilities will include:
- Writing & Executing Packaging Equipment/Process Qualifications, IQ/OQ/PQ Testing Protocols.
- Write Validation Summary Reports
- Validation of Documentation
- Execute Validations (Packaging, Process, TMV, etc.)
- Creating sample sizes, DOEs, etc.
- Medical Device: 5-8+ years
- Writing & Executing Packaging Equipment Validation Protocols/Documentation: 5-8+ years
- Extensive background validation Packaging Equipment
- Very strong communicator
- Able to work alongside engineers of all levels
Job Type: Contract