Senior Specialist - HVAC; Non-Sterile

Position: Senior Specialist - HVAC (Non-Sterile)

Position Summary

The Senior HVAC Specialist will be responsible for the reliable and compliant operation of HVAC systems supporting non-sterile pharmaceutical manufacturing facilities, including production, packaging, warehouses, and support areas. The role focuses on ensuring consistent environmental conditions, GMP compliance, and energy-efficient operations in line with pharmaceutical standards.

Key Responsibilities HVAC System Oversight

• Manage and optimize HVAC systems for non-sterile production areas, including temperature, humidity, and pressure control.
• Ensure proper zoning and segregation to prevent cross-contamination between different product types and manufacturing stages.

Compliance & Documentation

• Ensure all HVAC systems operate in compliance with cGMP, WHO guidelines, and company SOPs.
• Review and maintain documentation related to HVAC performance, maintenance, and change controls.
• Support validation and qualification efforts as per risk-based approaches suitable for non-sterile environments.

Maintenance & Reliability

• Lead the preventive and corrective maintenance programs for HVAC systems, including AHUs, chillers, exhaust systems, and ductwork.
• Monitor HVAC performance trends and address any deviations or inefficiencies promptly.

Project & Engineering Support

• Provide technical input for HVAC design in new non-sterile areas or expansion projects.
• Participate in project planning, equipment selection, commissioning, and qualification activities.
• Review HVAC-related engineering drawings, control logic, and system architecture.

Monitoring & Troubleshooting

• Ensure optimal air quality and environmental parameters in compliance with defined limits for non-sterile manufacturing zones.
• Investigate and resolve HVAC-related issues, including comfort concerns, air quality problems, or energy inefficiencies.

Continuous Improvement

• Identify opportunities to optimize HVAC energy consumption and improve operational efficiency.
• Participate in energy audits and sustainability initiatives where applicable.

Team Support & Training

• Mentor HVAC technicians and junior engineers.
• Support cross-functional teams by sharing HVAC knowledge, particularly during investigations or system upgrades.

Qualifications and Experience

• Bachelor’s degree in Mechanical Engineering, HVAC Engineering, or related discipline.
• Minimum 3–5 years of experience in HVAC systems for pharmaceutical non-sterile production environments.
• Knowledge of HVAC system design, AHU components, filtration levels (typically G4 to F9), and control systems (BMS).
• Familiar with regulatory expectations for oral solid dosage, liquid manufacturing, and non-sterile product areas.
• Experience in audits and technical support for regulatory inspections.

Key Competencies

• Sound knowledge of GMP standards, HVAC zoning for non-sterile facilities, and risk-based contamination control.
• Strong problem-solving, troubleshooting, and system optimization skills.
• Ability to interpret HVAC technical drawings, air balancing reports, and system specifications.
• Excellent communication, documentation, and teamwork skills.

Preferred Certifications

• HVAC system maintenance, energy efficiency, or engineering certifications (e.g., Certified HVAC Professional).
• Training in GMP compliance or pharmaceutical engineering fundamentals.

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