CQV Engineer

JDA WMS PTE. LTD.; Singapore; On-site; SGD 70,000 - 120,000; Full time

Job summary

JDA WMS PTE. LTD. seeks a CQV Engineer to support commissioning, qualification and validation of pharma/biotech facilities in Singapore. You will work with engineering, project and quality teams to ensure systems and equipment are commissioned and validated in line with GMP requirements.

The role requires hands-on experience with WFI, Clean Steam and HVAC, plus strong GMP/GAMP 5 knowledge. Mandarin communication with clients and project stakeholders is an advantage.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 2–5 years of CQV experience in pharma/biotech; 5+ for senior roles.
• Working experience in construction industry.
• Strong GMP, GAMP 5, ISPE guidance knowledge.
• Mandarin communication with stakeholders when required.

Responsibilities

• Plan, coordinate, and execute CQV activities for pharma/biotech facilities, utilities, and equipment.
• Prepare IQ/OQ/PQ protocols and reports per GMP, ISPE, and regulatory requirements.
• Collaborate with project, quality, and construction teams to meet schedules.

Skills

Communication

Coordination

Project management

Mandarin language

Education

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

Job description

About the Role

We are seeking a CQV Engineer to support the commissioning, qualification, and validation of pharmaceutical and biotechnology manufacturing facilities. The successful candidate will work closely with engineering, project, and quality teams to ensure systems, utilities, and equipment are commissioned and validated in compliance with GMP and regulatory requirements, enabling successful operational readiness.

Responsibilities

• Plan, coordinate, and execute commissioning, qualification, and validation (CQV) activities for pharmaceutical and biotechnology facilities, utilities, and process equipment.
• Prepare, review, and execute IQ, OQ, and PQ protocols and reports in accordance with GMP, GAMP 5, company procedures, and regulatory requirements.
• Work closely with engineering, project, quality, and construction teams to ensure CQV activities are completed according to project schedules.
• Investigate, troubleshoot, and resolve commissioning and validation issues during project execution.
• Ensure compliance with applicable pharmaceutical regulations and industry standards, including FDA, EMA, PIC/S, and relevant local authority requirements.
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), risk assessments, and commissioning activities for new or modified systems.
• Provide technical support throughout the design, construction, commissioning, and operational readiness phases of projects.
• Prepare and maintain CQV documentation to support regulatory inspections and project handover.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 2–5 years of experience in commissioning, qualification, and validation within the pharmaceutical or biotechnology industry (senior positions may require 5+ years of relevant experience).
• Must have working experience in the construction industry.
• Good knowledge of GMP, GAMP 5, ISPE Baseline Guides, and pharmaceutical regulatory requirements.
• Hands‑on experience with pharmaceutical utilities (e.g., WFI, Clean Steam, HVAC), process equipment, or cleanroom systems will be an advantage.
• Strong communication, coordination, and project management skills.
• Able to communicate in Mandarin to liaise with Mandarin‑speaking clients, contractors, suppliers, and project stakeholders where required.