Cqv Engineer - HVAC

AMTSOL is hiring for a greenfield pharmaceutical 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.