Senior HVAC Validation Engineer

Job Purpose

The Senior HVAC Validation Engineer will be responsible for the qualification, validation, testing, commissioning, and performance verification of HVAC and cleanroom systems used in pharmaceutical, healthcare, cosmetics, food, and other controlled environments.

The role requires strong practical knowledge of HVAC systems, cleanroom design, air balancing, environmental monitoring, HEPA filtration, pressure differentials, temperature/RH control, airflow patterns and applicable GMP/cleanroom standards.

The engineer will lead HVAC qualification and validation activities from protocol preparation through execution, report preparation, deviation management and final documentation.

Key Responsibilities

A. HVAC Qualification & Validation

Plan and execute qualification and validation activities for:

• AHUs and FAHUs
• HVAC systems
• Cleanrooms
• Controlled environments
• Manufacturing areas
• Sterile and non-sterile production areas
• Warehouses and storage areas
• Sampling and dispensing rooms
• Laboratories
• Microbiology and other controlled laboratory areas
• Healthcare and hospital controlled environments.

Perform and review:

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• HVAC qualification protocols
• HVAC performance verification
• Requalification activities.

B. Cleanroom Testing

Perform and/or supervise cleanroom testing including:

• Airflow velocity measurement
• Airflow volume measurement
• Air changes per hour (ACH/ACPH)
• Room pressure differential
• Temperature measurement
• Relative humidity measurement
• HEPA filter integrity/leak testing
• Non-viable particle counting
• Airflow visualization / smoke study
• Recovery testing
• Airflow direction verification
• Room classification testing
• Cleanroom pressure cascade verification.

Ensure testing is performed in accordance with approved protocols and applicable standards.

C. Cleanroom Standards & GMP

Working knowledge of:

• EU GMP Annex 1
• ISO 14644 series
• ISO 14644-1 – Cleanroom classification
• ISO 14644-2 – Monitoring
• ISO 14644-3 – Test methods
• WHO GMP
• US FDA GMP requirements
• PIC/S GMP
• ISPE Baseline Guides
• ASHRAE standards
• GAMP 5 where applicable.

Ability to determine appropriate acceptance criteria based on project specifications, URS, GMP requirements and applicable standards.

D. Protocol & Report Preparation

Prepare, execute and review:

• Validation Master Plan inputs
• HVAC DQ protocols
• IQ/OQ/PQ protocols
• HVAC qualification protocols
• Cleanroom qualification protocols
• Test procedures
• Risk assessments
• Sampling plans
• Calibration requirements
• Validation reports
• Requalification reports
• Deviation reports
• CAPA-related documentation.

Ensure complete traceability between URS, design specifications, drawings, equipment documentation, testing and qualification results.

F. HVAC Testing & Instrumentation

Experience with testing instruments such as:

• Anemometer
• Balometer
• Differential pressure meter/manometer
• Temperature/RH meter
• Particle counter
• Aerosol generator
• Photometer
• Data loggers
• Pressure gauges
• Airflow measuring instruments
• Tachometer
• Sound level meter where applicable.

Ensure all test instruments are calibrated and traceable before validation activities.

G. Air Balancing & Troubleshooting

• Review and verify TAB reports.
• Perform or supervise air balancing activities.
• Verify supply, return and exhaust airflow.
• Investigate pressure imbalance between rooms.
• Troubleshoot temperature and humidity deviations.
• Investigate HVAC capacity and airflow issues.
• Identify causes of cleanroom pressure instability.
• Verify HEPA filter installation and integrity.
• Support HVAC commissioning and troubleshooting activities.

H. Client & Project Management

• Lead HVAC validation activities at client sites.
• Coordinate with QA, Engineering, Production, Projects and Facility teams.
• Coordinate with HVAC contractors and TAB agencies.
• Review HVAC drawings, specifications and commissioning documents.
• Participate in client technical meetings.
• Provide technical recommendations and solutions.
• Manage validation schedules and deliverables.
• Ensure projects are completed within agreed timelines.

I. Team Leadership

• Lead HVAC validation engineers and technicians.
• Allocate validation activities and monitor execution.
• Review work performed by junior engineers.
• Train team members on cleanroom testing and HVAC qualification.
• Ensure correct use and handling of testing instruments.
• Maintain high standards of technical documentation.

Technical Competencies

The candidate should have strong knowledge of:

• HVAC system design and operation.
• Cleanroom design principles.
• Airflow and pressure cascade.
• HVAC heat-load fundamentals.
• Air changes and airflow calculations.
• HEPA filtration.
• Cleanroom classification.
• HVAC controls and BMS.
• TAB and air balancing.
• HVAC qualification.
• GMP and validation documentation.
• Risk assessment and criticality assessment.
• Deviation and CAPA management.
• Calibration and traceability of validation instruments.

Preferred Qualifications

• Bachelor's/Diploma degree in Mechanical Engineering, HVAC Engineering, Instrumentation or equivalent.
• 5–10 years of relevant HVAC qualification/validation experience.
• Strong experience in pharmaceutical HVAC and cleanroom validation.
• Experience with pharmaceutical manufacturing projects is highly preferred.
• Experience with sterile manufacturing and EU GMP Annex 1 will be an advantage.
• Experience in UAE/GCC pharmaceutical or healthcare projects is desirable.

Key Performance Indicators

• Timely completion of HVAC qualification projects.
• Accuracy of test results and reports.
• Compliance with approved protocols.
• Quality of validation documentation.
• Effective handling of deviations.
• Customer satisfaction.
• Technical accuracy of HVAC troubleshooting.
• Productivity and utilization of validation team.
• Compliance with GMP, safety and client requirements.

Personal Attributes

• Strong technical and analytical skills.
• Excellent troubleshooting ability.
• Strong written and verbal communication.
• Good understanding of GMP documentation.
• Leadership and team-management capability.
• Ability to work independently at client sites.
• Professional client-handling skills.
• Ability to manage multiple projects and deadlines.
• Willingness to travel to pharmaceutical and healthcare sites.

Reporting

Reports To: Validation Manager / Head – Validation & Engineering

Supervises: HVAC Validation Engineers / Validation Technicians / Junior Engineers

Work Location: In person