CQV Engineer

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.

  If interested, please submit your application to ***email_hidden*** with your expected salary and resume.

  We regret that only short-listed candidates will be contacted shortly. By submitting your application or resume, you agree to the collection, use, retention, and sharing of your personal information with potential employers for their assessment.

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

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