CQV engineer

Job Title

Role Accountabilities:

• Become familiar with the user, functional, installation, operation and performance requirements for assigned projects and tasks.
• Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications), for use in development of equipment commissioning and validation documents.
• Equipment validation protocol development, including drafting documents, managing review cycles and protocol approval.
• Support Validation Master Plan development
• Execution of equipment validation protocols (including use of Kaye Validator/temperature monitoring for autoclaves, SIP Systems, washer COP, CIP, FITs, etc.)
• Support Equipment Validation Report development, including drafting documents, managing review cycles and protocol approval.
• Support Validation Summary Report development
• Preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system).
• Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation.
• Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.).
• Support 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…)
• Support developing SOP's.
• Other tasks as requested or required by Client to support Equipment Validation for each project.
• Preform CQV activities on process equipment including but not limited to…
• Other duties as assigned