The Validation Engineer II ensures compliance and operational excellence by managing validation processes across sterile and non-sterile manufacturing.
It oversees multiple projects, develops documentation, and collaborates with teams to enhance efficiency, support product development, and drive continuous improvement aligned with our mission to provide high-quality, accessible medications.
ESSENTIAL JOB FUNCTIONS:
Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and processes, and developing key validation documentation, including Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Performance Qualification, and Process Qualification for sterile and non-sterile manufacturing.