Job Description

Senior Specialist – HVAC (Non-Sterile)

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.