CQV engineer

Job Title

The role involves becoming familiar with user, functional, installation, operation, and performance requirements for assigned projects and tasks. It includes reviewing requirements and source documentation such as P&IDs, RDs, URSs, SOPs, and specifications for use in developing equipment commissioning and validation documents. The role also entails equipment validation protocol development, including drafting documents, managing review cycles, and protocol approval. Additionally, it supports Validation Master Plan development and execution of equipment validation protocols, including the use of Kaye Validator/temperature monitoring for autoclaves, SIP Systems, washer COP, CIP, FITs, etc.

Supporting Equipment Validation Report development, including drafting documents, managing review cycles, and protocol approval, is also part of the role. It involves supporting Validation Summary Report development and preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system). The role provides support for generation, resolution, and closure of Equipment Validation related deviations and required documentation. It assists with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.) and supports resolution of engineering/validation issues found during equipment validation.

Attending meetings as required to support equipment installation and operation, providing quality oversight and approval for validation documents as needed (Function test, IQs, OQs, etc…), and supporting developing SOP's are also included. The role supports other tasks as requested or required by Client to support Equipment Validation for each project and performs CQV activities on process equipment including but not limited to…

Other duties as assigned.