- Carlsbad, California
- Pharma & Biotech, Medical Devices, Quality Assurance, Quality Assurance
My client is a large medical device company that specializes in the production of artificial human tissue. The validation aspect is part of a recent take over of a small biologics company. A gap assessment has been performed and now they are in need of a qualified validation engineer to support execution and remediation of equipment validation in a clean room.
- Working in a Medical Device/Human Tissue clean-room processing facility
- Writing validation (IQ/OQ/PQ) protocols
- Executing validation protocols
- Writing final validation reports
- Cleaning validations
- Sterilization validations
- Equipment validation
- Environmental monitoring equipment validations/facility validations
- Medical Device: 7+ plus years
- Equipment/Clean Room Validation
- Validation Gap Assessment experience
- ISO 13485
Sthree US is acting as an Employment Business in relation to this vacancy.