Cleanroom HVAC Systems Supervisor

We are seeking a skilled and detail-oriented Cleanroom HVAC Systems Supervisor (Mid-Level) to oversee the operation, maintenance, and performance of HVAC systems in controlled cleanroom environments. The ideal candidate will have hands-on experience with cleanroom-grade HVAC infrastructure and will supervise daily operations to ensure regulatory compliance, optimal environmental conditions, and minimal downtime.

Key Responsibilities:

HVAC System Operation & Monitoring

• Manage the day-to-day functioning of HVAC systems (AHUs, chillers, ductwork, HEPA filters, pressure balancing, humidity & temperature control).

• Monitor and respond to Building Management System (BMS) data, alerts, and performance trends.

• Ensure environmental conditions in cleanrooms meet ISO 14644 and GMP standards consistently.

Maintenance Oversight

• Plan and supervise preventive and corrective maintenance activities for cleanroom HVAC systems.

• Ensure timely resolution of HVAC malfunctions or deviations using root cause analysis (RCA) and implementation of corrective actions.

• Supervise HEPA filter integrity testing, airflow velocity checks, and differential pressure validations.

Regulatory Compliance & Documentation

• Maintain accurate records of maintenance, calibrations, validations, and deviations.

• Support audits and inspections by ensuring all documentation is up-to-date and compliant with GMP, FDA, and ISO regulations.

• Collaborate with Quality Assurance to address non-conformities and implement continuous improvement actions.

Team Supervision

• Supervise and train junior technicians and HVAC maintenance staff.

• Ensure compliance with cleanroom protocols, gowning standards, and safety guidelines.

• Coordinate work with other departments (production, quality, validation) to minimize downtime and maximize system performance.

Project Participation

• Assist in the design, planning, and execution of HVAC upgrades, retrofits, and system expansions.

• Work with vendors, contractors, and OEMs for equipment installation, troubleshooting, or validation support.

Key Focus Areas:

1. Cleanroom HVAC Operations

2. BMS Monitoring & Performance Analysis

3. Preventive Maintenance Scheduling & Execution

4. ISO 14644 & GMP Compliance

5. Technical Documentation & Reporting

6. HEPA Filtration and Airflow Testing

7. Root Cause Analysis (RCA) & CAPA Implementation

8. Cleanroom Audit Readiness

9. Team Leadership & Training

10. Vendor & Project Coordination

Qualifications:

• Diploma or Bachelor’s degree in Mechanical Engineering, HVAC Technology, or equivalent.

• 4–7 years of hands-on experience in cleanroom HVAC systems (preferably in pharmaceutical, semiconductor, or biotech industries).

• Strong knowledge of cleanroom standards (ISO 14644, GMP, FDA).

• Familiarity with HVAC drawings, P&IDs, and airflow balancing reports.

• Proficiency with Building Management Systems (BMS) and maintenance software (e.g., CMMS).

Desired Skills:

• Strong understanding of HVAC mechanical systems and cleanroom environmental controls.

• Ability to lead a team and coordinate activities across departments.

• Effective problem-solving, communication, and documentation skills.

• Attention to detail and a commitment to safety and compliance.

• Experience with HVAC system commissioning, validation (IQ/OQ/PQ), and audit preparation.