Job Description
Senior Validation Engineer – 503A Sterile Compounding
The Senior Validation Engineer is responsible for leading validation, qualification, requalification, environmental monitoring, shipping studies, and sterility assurance activities supporting both sterile and non-sterile compounding pharmacy operations. This role supports compliance with USP <797>, USP <795>, USP <800>, USP <1079>, applicable FDA guidance, and industry best practices across sterile, non-sterile, and hazardous drug (HD) compounding operations.
The position works cross-functionally with Quality Assurance, Pharmacy Operations, Engineering, Facilities, and external vendors to support sterile manufacturing operations, regulatory readiness, and continuous quality improvement initiatives.
This role is highly hands-on and requires strong technical writing, investigation, risk assessment, and project management skills within regulated compounding environments. <...