Role Summary
The CQV Engineer will provide project validation support, conducting equipment performance qualifications, authoring project validation master plans, SOP and documentation updates, and executing validation studies. They will also oversee equipment C&Q within the assigned area to ensure right first-time C&Q and Validation effort.
Key Responsibilities:
* Conduct equipment performance qualifications, including cleaning and sterilization validation.
* Author project validation master plans, SOP and documentation updates, and validation protocols.
* Execute validation studies and analyze validation data.
* Resolve technical issues encountered during study execution.
* Review and approve commissioning, qualification, and validation protocols executed by vendors or cross-functional groups.
Requirements:
* Minimum 6 years of experience in C&Q, QA, QC, or Validation in a highly regulated industry.
* Minimum 2 years of process equipment C&Q/ QA/ Validation experience on Greenfield/Brownfield, Large Scale Project, or new facility introduction.
* Expertise in Equipment Qualification, including Cleaning & Parts Washers, Vaporised Hydrogen Peroxide Isolators, Clean Utilities & Transfer Panels, Vial & Syringe Filling & Inspection.