Cleanroom HVAC Systems Supervisor

We are looking for a highly experienced and knowledgeable Senior Cleanroom HVAC Systems Supervisor to lead the planning, operation, and optimization of HVAC systems that support cleanroom environments. The ideal candidate will have a strong background in HVAC system design, compliance standards (GMP, ISO 14644), and team leadership. This role is critical in ensuring all cleanroom operations meet environmental and regulatory standards for high-performance production environments such as pharmaceuticals, semiconductors, or biotech.

Key Responsibilities:

1. HVAC System Leadership & Oversight

• Lead and oversee the operation, maintenance, and performance of HVAC systems supporting ISO/GMP cleanrooms.

• Ensure consistent environmental controls (temperature, humidity, pressure differential, particulate levels) across all cleanroom areas.

• Monitor and optimize Building Management System (BMS) performance to ensure energy efficiency and system integrity.

2. Maintenance Management

• Develop and implement preventive and predictive maintenance programs.

• Supervise the execution of corrective maintenance, ensuring minimal downtime and compliance with quality and safety standards.

• Manage critical spares inventory and maintenance scheduling using CMMS tools.

3. Compliance & Quality Assurance

• Ensure all HVAC systems comply with regulatory requirements (GMP, FDA, ISO 14644, EU Annex 1).

• Lead internal audits and participate in regulatory inspections related to cleanroom environmental controls.

• Maintain documentation including system drawings, maintenance logs, calibration records, and validation reports.

4. Validation & Qualification

• Oversee HVAC system qualification activities including DQ, IQ, OQ, and PQ.

• Coordinate with validation, quality, and production teams to support requalification and environmental monitoring programs.

5. Team & Project Management

• Lead a team of HVAC technicians and junior supervisors, providing technical training and performance feedback.

• Collaborate with cross-functional teams on facility expansion, cleanroom upgrades, and system retrofits.

• Manage contractors and vendors for major HVAC installations, upgrades, and third-party testing.

6. Continuous Improvement

• Analyze HVAC performance data to identify trends, inefficiencies, and areas for improvement.

• Propose and implement system upgrades, energy-saving initiatives, and process optimizations.

Key Focus Areas:

1. Cleanroom HVAC Performance & Reliability

2. GMP & ISO 14644 Regulatory Compliance

3. Preventive and Predictive Maintenance

4. BMS Monitoring & Optimization

5. Validation/Qualification Management (IQ/OQ/PQ)

6. Team Supervision & Skill Development

7. CAPA Implementation & Root Cause Analysis

8. Audit Preparedness & Documentation Control

9. Vendor & Contractor Oversight

10. Energy Efficiency & System Optimization

Qualifications:

• Bachelor’s degree or Diploma in Mechanical Engineering, HVAC Technology, or a related field.

• 7–10+ years of progressive experience in cleanroom HVAC operations, with at least 3 years in a supervisory role.

• Deep knowledge of cleanroom classifications, HVAC systems, and regulatory requirements (GMP, FDA, ISO 14644, EU Annex 1).

• Proficiency in HVAC system diagnostics, BMS platforms, and technical documentation.

• Experience managing cross-functional projects and leading audit-related activities.

Skills & Competencies:

• Strong leadership and team management skills.

• Expertise in cleanroom environmental control systems.

• Excellent problem-solving, root cause analysis, and decision-making skills.

• Strong communication and interpersonal skills across engineering, quality, and operations teams.

• Familiarity with commissioning/qualification protocols and facility validation standards.