CQV Engineer

MORIMATSU PHARMADULE (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 60,000 - 120,000; Full time

Job summary

MORIMATSU PHARMADULE (SINGAPORE) PTE. LTD. is seeking a CQV Engineer to support the start-up and validation of state-of-the-art pharmaceutical/biotech manufacturing facilities in Singapore.

The role involves collaborating with project, engineering, and quality teams to ensure all systems meet GMP compliance and are ready for commercial production. You will plan, execute and review CQV activities (IQ/OQ/PQ), coordinate with cross-functional teams, and ensure timely execution while adhering to

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 2–5 years in commissioning/qualification/validation in pharma/biotech.
• Familiar with GMP, GAMP 5, ISPE Baseline Guides and pharma regulations.
• Hands-on with utilities (WFI, clean steam, HVAC) and process equipment.
• Strong communication and project coordination skills.

Responsibilities

• Plan, execute and manage CQV activities for pharma/biotech facilities, utilities and equipment.
• Develop and review IQ/OQ/PQ protocols and reports per GMP.
• Coordinate with engineering, project and quality teams for timely CQV execution.
• Troubleshoot CQV issues during project execution.
• Ensure compliance with FDA/EMA/PIC/S guidelines.
• Support FAT, SAT and risk assessments for new or modified systems.
• Provide technical input during design, construction, and operations readiness.

Skills

Project coordination

Communication skills

GMP knowledge

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

WFI

Clean Steam

HVAC

Job description

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.