CQV Engineer

4 days ago

Singapore GOOD JOB CREATIONS (SINGAPORE) PTE. LTD. Full time

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. Perform any other ad-hoc tasks assigned by management. Requirements: 3 years of experience in commissioning, qualification, or validation in pharmaceutical or biotech industries. 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. Bachelor’s degree in Engineering, Life Sciences, or related field. We are an equal opportunities employer and welcome applications from all qualified candidates. #J-18808-Ljbffr

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