Job Description
Role: Qualification and Validation Analyst, on-site in Boston, MA / Indianapolis, IN - Full-time
Locations: Boston, MA / Indianapolis, IN
Job description: 381981- 380069/HE
Must Have Technical/Functional Skills
Experience Required: 3 - 10 + Years
- Experience in executing equipment validation, including IQ/PQ/OQ in a regulated environment
- Experience supporting in a GMP environment
- Excellent written and verbal communication skills
- Roles & Responsibilities
- Author equipment qualification and validation packages
- Plan coordination with the 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