CQV Engineer - HVAC at Advanced Manufacturing Tech Solutions (AMTSOL)

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

16 Oct, 26

Salary

0.0

Posted On

18 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

HVAC CQV, Cleanroom Qualification, EU GMP Annex 1, ISO 14644, IQ/OQ/PQ, HEPA Filter Integrity Testing, Airflow Visualisation, BMS/EMS Verification, Technical Writing, Stakeholder Management, Risk Assessment, Change Control

Industry

Pharmaceutical Manufacturing

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.

Responsibilities

Execute the commissioning, qualification, and validation of HVAC systems and Grade C/D cleanrooms in compliance with EU GMP and ISO standards. Develop and review qualification protocols, manage deviations, and coordinate with cross-functional teams to achieve project milestones.