CQV Engineer - HVAC

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AMTSOL in Singapore is seeking an HVAC CQV Engineer 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 quality requirements.

You will develop qualification protocols, perform testing, and produce final reports, while coordinating with QA, Engineering, and Operations to achieve project milestones and ensure inspection-ready documentation.

Qualifications

• Minimum 5 years of HVAC and cleanroom CQV experience in pharmaceutical/biotech settings.
• Strong knowledge of EU GMP Annex 1 and ISO 14644 cleanroom standards.
• Experience with IQ/OQ/PQ, deviations, and qualification reporting.
• Hands-on cleanroom qualification testing and documentation.

Responsibilities

• Develop, review, and execute HVAC/cleanroom qualification protocols (IQ, OQ, PQ).
• Qualification of AHUs, HVAC systems, ducting, and Grade C/D cleanrooms.
• Plan and review cleanroom certification tests including airflow, HEPA, and temperature mapping.
• Coordinate with QA, Engineering, Operations, and validation teams to meet milestones.
• Maintain inspection-ready GMP documentation.

Skills

HVAC CQV

Pharma Industry

GMP ISO

Documentation

Stakeholder Mgmt

Education

Bachelor's degree in Mechanical Engineering

Chemical Engineering

Tools

EMS/BMS systems

HVAC controls software

Job description

Overview

AMTSOL is supporting a pharmaceutical manufacturing project in Singapore and is seeking an HVAC CQV Engineer 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 quality requirements.

Key Responsibilities

• Develop, review, and execute HVAC and cleanroom qualification protocols, including IQ, OQ, PQ, requalification, discrepancy records, and final reports.
• Perform qualification of AHUs, HVAC systems, ducting, controls, HEPA filtration systems, temperature, humidity, differential-pressure controls, and Grade C/D cleanrooms.
• Plan, execute, and review cleanroom certification testing, including airflow visualisation/smoke studies, air-velocity measurements, air-change calculations, HEPA filter integrity testing, non-viable particle monitoring, room pressurisation verification, and temperature/humidity mapping.
• Support FAT, SAT, commissioning, start-up, system balancing, punch-list management, and handover activities.
• Review vendor and contractor documentation, test evidence, calibration records, and turnover packages.
• Manage deviations, change controls, punch-list items, risk assessments, and qualification actions through closure.
• Coordinate with QA, Engineering, Operations, Automation, Facilities, contractors, and validation teams to achieve project milestones.
• Support verification of EMS/BMS monitoring and HVAC automation controls where they form part of the qualified system.
• Maintain accurate, inspection-ready documentation in accordance with GMP and Good Documentation Practices.

Requirements

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Building Services, or a related discipline.
• Minimum 5 years of HVAC and cleanroom CQV experience within pharmaceutical or biotechnology facilities.
• Strong knowledge of EU GMP Annex 1, ISO 14644 cleanroom standards, ISPE Baseline Guides, and Good Documentation Practices.
• Hands-on experience with cleanroom qualification testing, HVAC control verification, deviations, and qualification reporting.
• Strong technical writing, troubleshooting, planning, and stakeholder-management skills.

Preferred / Advantageous

• Experience with sterile manufacturing or aseptic-processing environments, including isolators.
• Experience leading cleanroom qualification or requalification programmes.
• Familiarity with EMS/BMS systems and HVAC automation controls.