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.
