Validation Engineer

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