CQV Engineer

About the role

Join our team as a CQV (Commissioning, Qualification & Validation) Engineer , supporting the start-up and validation of state-of-the-art pharmaceutical/biotech manufacturing facilities. You will work closely with project, engineering, and quality teams to ensure all systems meet GMP compliance and are ready for commercial production. Job Responsibilities Plan, execute, and manage commissioning, qualification, and validation (CQV) activities for pharmaceutical/biotech manufacturing facilities, utilities, and process equipment. Develop and review CQV protocols (IQ/OQ/PQ) and reports in compliance with GMP, GAMP 5, and company procedures. Coordinate with engineering, project, and quality teams to ensure timely CQV execution. Troubleshoot and resolve CQV-related issues during project execution. Ensure adherence to regulatory requirements (e.g., FDA, EMA, PIC/S) and local health authority guidelines. Support FAT, SAT, and risk assessments for new or modified systems. Provide technical input during design, construction, and operational readiness stages. Job Requirements Bachelor's degree in Engineering, Life Sciences, or related field. 2-5 years of experience in commissioning/qualification/validation in pharmaceutical or biotech industries (senior roles may require 5+ years). Familiar with GMP, GAMP 5, ISPE Baseline Guides, and pharmaceutical regulations. Hands-on experience with utilities (e.g., WFI, clean steam, HVAC), process equipment, or cleanroom systems preferred. Good communication and project coordination skills.

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Company Intel

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