What are the responsibilities and job description for the CSV Engineer position at Katalyst CRO?
Roles & Responsibilities
- Author equipment qualification and validation packages
- Plan coordination with equipment manufacturer or supplier for preventative maintenance
- Technical review and execution of qualification/validation protocols
- Execution of CSV initiatives
- Apply knowledge of quality principles, GMPs, federal regulations and standard procedures to deliverables
- Initiate CSV change controls on equipment
- Experience Required: 2-4 Years
- Experience in executing equipment validation including
- IQ/PQ/OQ in regulated environment
- Experience supporting in a GMP environment
- Excellent written and verbal communication skills