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.
Morimatsu Group has delivered projects to more than 40 countries/regions in the world, established an excellent industrial reputation in the process.
Morimatsu is dedicated in providing core equipment, process systems, integrated engineering solutions, modular plants, and digital operations for life sciences, fast-moving consumer goods, and electronics industries.
Our highly skilled professional teams, which include project managers, design engineers, validation experts, and operational technicians, continuously bringing clients the most advanced industrial concepts as well as cutting-edge technologies.