Design Engineer

Cleanroom & HVAC Design Engineer Roles and Responsibilities

1. Cleanroom Design & Classification

• Design cleanrooms as per

  ISO 14644 / GMP / FDA / WHO

  standards.
• Define cleanroom

  classifications (ISO 5, 6, 7, 8)

  based on process requirements.
• Plan

  room zoning

  , pressure cascades, and personnel/material flow.
• Ensure compliance with pharmaceutical, biotech, electronics, or medical device norms.
  

2. HVAC System Design

• Calculate

  heat load

  (equipment, people, lighting, envelope).
• Design HVAC systems for

  temperature, humidity, and air cleanliness control

  .
• Select suitable

  AHUs, chillers, FCUs, DX systems

  .
• Design

  air distribution

  using laminar flow or turbulent flow as required.
• Determine

  air change rates (ACPH)

  and fresh air requirements.

3. Filtration & Airflow Control

• Select and size

  Pre-filters, Fine filters, HEPA/ULPA filters

  .
• Design

  terminal HEPA filter layouts

  and airflow patterns.
• Ensure proper

  air velocity, uniformity, and recovery time

  .
• Plan return air, exhaust air, and pressure control systems.
  

4. Pressure Differential Management

• Design

  pressure cascades

  between clean and less-clean areas.
• Ensure compliance with required

  pressure differentials (10–15 Pa)

  .
• Design airlocks, pass boxes, and interlocking systems.
  

5. Ducting & Mechanical Layout

• Prepare

  HVAC GA drawings

  , duct routing, and diffuser layouts.
• Size ducts considering

  velocity, noise, and pressure drop

  .
• Coordinate with architectural, electrical, plumbing, and process teams.
  
• Design vibration isolation and noise control measures.
  

6. Controls & Automation

• Define

  BMS / EMS

  control philosophy.
• Specify sensors for

  temperature, RH, pressure, and airflow

  .
• Develop control logic for

  VAV, CAV, night setback, and alarms

  .
• Ensure data logging for regulatory compliance.
  

7. Energy Efficiency & Sustainability

• Optimize systems for

  energy efficiency

  and life-cycle cost.
• Implement heat recovery systems where applicable.
  
• Select energy-efficient motors, fans, and control strategies.
  
• Comply with local energy codes and green building standards.
  

8. Compliance, Validation & Documentation

• Prepare

  URS, DQ, IQ, OQ, PQ

  documents for HVAC & cleanrooms.
• Support

  commissioning and validation activities

  .
• Review test reports for

  airflow, particle count, recovery time

  .
• Ensure systems meet regulatory audit requirements.
  

9. Installation Support & Site Coordination

• Provide technical support during

  fabrication and installation

  .
• Review shop drawings and material submittals.
  
• Coordinate with contractors for correct execution.
  
• Conduct site inspections and resolve technical issues.
  

10. Testing, Balancing & Commissioning

• Oversee

  TAB (Testing, Adjusting & Balancing)

  .
• Verify airflow rates, pressure differentials, and filter integrity.
  
• Support

  HEPA integrity testing (PAO/DOP)

  .
• Ensure final system performance meets design intent.