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

• Bachelors 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.