CQV Engineer

About the Role We are seeking a CQV Engineer to support the commissioning, qualification, and validation of pharmaceutical or biotechnology manufacturing facilities. The role will work with engineering, project, construction, and quality teams to ensure facilities, utilities, and equipment are compliant with GMP requirements and ready for operation. Job Scope

• Plan, coordinate, and execute commissioning, qualification, and validation activities for facilities, utilities, process equipment, and cleanroom systems.

• Develop, review, and execute IQ, OQ, and PQ protocols, test scripts, reports, and supporting documentation.

• Coordinate CQV activities with engineering, construction, vendors, quality teams, and project stakeholders.

• Support Factory Acceptance Tests, Site Acceptance Tests, system turnover, risk assessments, and operational-readiness activities.

• Review design documents, specifications, drawings, and vendor submissions from a commissioning and validation perspective.

• Investigate test failures, deviations, and CQV-related issues and coordinate appropriate corrective actions.

• Ensure CQV deliverables comply with GMP, GAMP 5, company procedures, and relevant regulatory requirements.

• Provide technical support during design, construction, equipment installation, system start-up, and project handover.

• Maintain accurate CQV documentation and support regulatory, client, and internal quality audits.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Science, or a related discipline.

• Approximately 2–5 years of relevant commissioning, qualification, or validation experience in pharmaceutical or biotechnology projects.

• More extensive experience may be considered for a senior-level appointment.

• Familiar with GMP, GAMP 5, ISPE guidance, FDA, EMA, PIC/S, and applicable local regulatory requirements.

• Experience preparing or executing IQ, OQ, and PQ documentation.

• Practical experience with pharmaceutical utilities, HVAC, WFI, clean steam, process equipment, automation, or cleanroom systems is preferred.

• Familiar with FAT, SAT, risk assessments, deviations, change control, and system handover processes.

• Good technical-writing, communication, coordination, and problem-solving skills.

• Able to work effectively with multidisciplinary project, engineering, construction, vendor, and quality teams.

If interested, please submit your application to [email protected] 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