Job Orders

• Pharmaceutical Manufacturing

• HVAC Commissioning
• Qualification & Validation (CQV)
• Cleanroom Qualification
• Pharmaceutical / Biotechnology Facilities
• GMP Manufacturing Environment
• Mechanical Engineering
• HVAC Systems & Controls

• Detail-oriented with strong compliance mindset
• Strong technical documentation skills
• Good problem-solving and troubleshooting ability
• Effective communication and coordination skills
• Able to manage multiple stakeholders
• Independent and proactive working style
• Strong planning and organisational skills

The HVAC CQV Engineer will be responsible for the commissioning, qualification, and validation of HVAC systems and cleanrooms within pharmaceutical and biotechnology facilities. The role involves ensuring HVAC systems comply with GMP requirements, cleanroom standards, and internal quality procedures.

Key Responsibilities:

• Develop and execute HVAC and cleanroom qualification protocols including IQ, OQ, and PQ.
• Perform qualification activities for:

1. HVAC systems, AHUs, ducting, and control systems
2. HEPA filtration systems
3. Temperature, humidity, and pressure control systems
4. Grade C & D cleanrooms

• Conduct and review cleanroom certification testing, including:

1. Airflow visualization (smoke studies)
2. Air velocity measurement
3. Air change rate calculations
4. HEPA filter integrity testing
5. Non-viable particle monitoring
6. Room pressurization verification
7. Temperature and humidity mapping

• Support FAT, SAT, commissioning, and requalification activities.
• Manage deviations, change controls, punch lists, and qualification reports.
• Collaborate with QA, Engineering, Operations teams, and external contractors.
• Support cleanroom qualification and requalification programmes.

• Mechanical Engineering
• Chemical Engineering

• English

• English

• Others

• Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, Building Services Engineering, or related disciplines.
• Minimum 5 years of HVAC / Cleanroom CQV experience within pharmaceutical or biotechnology facilities.
• Strong experience in qualification of HVAC systems and cleanrooms.
• Good knowledge of:EU GMP Annex 1

1. ISO 14644 Cleanroom Standards
2. ISPE Baseline Guides
3. Good Documentation Practices (GDP)

• Experience with sterile manufacturing facilities and aseptic processing environments (e.g. isolators) will be an advantage.
• Familiarity with EMS/BMS systems and HVAC automation controls.
• Strong technical writing and report preparation skills.
• Good troubleshooting, problem-solving, and stakeholder management skills.
• Ability to work independently and effectively within multidisciplinary project teams.