CQV (Commissioning, Qualification & Validation) Engineer

JDA WMS PTE. LTD.; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

JDA WMS Pte Ltd in Singapore is seeking a qualified CQV Engineer to lead commissioning, qualification, and validation activities for pharmaceutical facilities.

You will collaborate with engineering, project, and quality teams to ensure utilities, clean rooms, and process equipment meet GMP and regulatory standards, and support startup phases.

Qualifications

• Bachelor's degree in engineering or life sciences.
• 2–5 years hands-on CQV experience in biopharma.
• Solid GMP, GAMP 5, ISPE Baseline familiarity.
• Experience with utilities and cleanroom environments preferred.

Responsibilities

• CQV Lifecycle Management: Plan, prepare, and execute commissioning, qualification, and validation activities across pharmaceutical utilities, process equipment, and facility systems.
• Protocol & Documentation: Author and review IQ/OQ/PQ protocols and execution reports in alignment with GMP, GAMP 5, and organizational guidelines.
• Testing & Inspection: Support FAT, SAT, and risk management activities for new or modified equipment.
• Regulatory Governance: Ensure compliance with FDA, EMA, PIC/S and local health authority standards.
• Cross-Functional Collaboration: Partner with engineering, quality, and construction teams to resolve deviations and support startup.

Skills

CQV Experience

Regulatory Knowledge

Cross-functional Collaboration

GMP Familiarity

Education

Bachelor's Degree in Engineering/Life Sciences

Tools

GAMP 5

ISPE Baseline Guides

Job description

Position Overview

We are seeking a qualified CQV Engineer to join our project team in driving commissioning, qualification, and validation initiatives for advanced pharmaceutical and biotech manufacturing facilities. Working collaboratively across engineering, project, and quality functions, you will ensure facility systems, clean utilities, and process equipment satisfy strict regulatory standards and operational readiness goals.

Key Responsibilities

• CQV Lifecycle Management: Plan, prepare, and execute commissioning, qualification, and validation activities across pharmaceutical utilities, process equipment, and facility systems.


• Protocol & Documentation: Author and review IQ/OQ/PQ protocols and execution reports in strict alignment with GMP, GAMP 5, and organizational guidelines.


• Testing & Inspection: Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and risk management activities for new or modified equipment.


• Regulatory Governance: Ensure full compliance with international regulatory frameworks (FDA, EMA, PIC/S) and local health authority standards.


• Cross-Functional Collaboration: Partner with engineering, quality, and construction teams to resolve technical deviations, provide design inputs, and support operational startup.

Requirements

• Education: Bachelor's Degree in Engineering, Life Sciences, or a related discipline.


• Experience: 2 to 5 years of hands-on CQV experience within the biopharmaceutical or life sciences sector.


• Technical Standards: Solid familiarity with GMP, GAMP 5, ISPE Baseline Guides, and international regulatory expectations.


• Utility & Equipment Expertise: Hands-on background with pharmaceutical utilities (WFI, Clean Steam, HVAC), process machinery, or cleanroom environments.


• Core Competencies: Strong technical problem-solving capabilities alongside effective cross-team coordination skills.

JDA WMS Pte Ltd | EA Personnel: Pham Thi Tuyet Mai

EA License No: 23S1595 | EA Registration No: R25127838