HVAC CQV Engineer: Cleanroom Validation Lead

Advanced Manufacturing Tech Solutions; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AMTSOL is seeking an HVAC CQV Engineer in Singapore to execute commissioning, qualification, and validation of HVAC systems and Grade C/D cleanrooms in line with EU GMP Annex 1, ISO 14644, and site requirements.

You will develop and run IQ/OQ/PQ protocols, manage deviations, and coordinate with QA, Engineering, Operations, and validation teams to achieve milestones while maintaining GMP-ready documentation.

Qualifications

• 5+ years of HVAC and cleanroom CQV experience in pharma/biotech facilities.
• Strong knowledge of EU GMP Annex 1, ISO 14644, ISPE Baseline Guides, and GDP.
• Hands-on experience with cleanroom qualification testing, control verification, deviations, and reporting.

Responsibilities

• Develop, review, and execute HVAC and cleanroom qualification protocols (IQ/OQ/PQ, requalification, reports).
• Qualification of AHUs, HVAC systems, ducting, controls, HEPA filtration, and Grade C/D cleanrooms.
• Plan and review cleanroom certification testing (airflow, particles, mapping).
• Support FAT, SAT, commissioning, start-up, and handover activities.
• Review vendor/contractor documentation, test evidence, and turnover packages.
• Manage deviations, change controls, risk assessments, and closure actions.
• Coordinate with QA, Engineering, Operations, and validation teams to milestones.
• Verify EMS/BMS monitoring where part of the qualified system.
• Maintain inspection-ready GMP-compliant documentation.

Skills

Technical writing

Troubleshooting

Planning

Stakeholder management

HVAC control verification

Education

Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Building Services, or related discipline

Tools

EMS/BMS systems

Job description

AMTSOL is seeking an HVAC CQV Engineer in Singapore to execute commissioning, qualification, and validation of HVAC systems and Grade C/D cleanrooms in line with EU GMP Annex 1, ISO 14644, and site requirements.

You will develop and run IQ/OQ/PQ protocols, manage deviations, and coordinate with QA, Engineering, Operations, and validation teams to achieve milestones while maintaining GMP-ready documentation.