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Title:  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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