CQV Engineer
3 weeks ago
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.
- 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.
Biochemistry
Lean Manufacturing
Regulatory Compliance
Manufacturing Processes
GMP
Investigation
GAMP
Microbiology
Biotechnology
Process Engineering
Change Control
Regulatory Requirements
Health Sciences
Manufacturing
Commissioning
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