Senior Specialist - HVAC (Sterile)

Job Description

Position Summary

The Senior HVAC Specialist will be responsible for overseeing the design, operation, maintenance, and compliance of Heating, Ventilation, and Air Conditioning (HVAC) systems in sterile pharmaceutical manufacturing environments. The role ensures that all HVAC systems support GMP and regulatory requirements critical for aseptic production and cleanroom classifications.

Key Responsibilities

• - Lead the operation, maintenance, and continuous improvement of HVAC systems serving sterile production and classified cleanrooms (ISO 5, 7, 8 / Grade A-D).
• Ensure environmental control and compliance with temperature, humidity, pressure differentials, airflow patterns, and particulate levels.

• - Ensure all HVAC operations are compliant with cGMP, EU GMP Annex 1, FDA 21 CFR Part 210/211, and other relevant guidelines.
• Prepare and review validation protocols (DQ, IQ, OQ, PQ) for HVAC systems.
• Participate in regulatory audits and provide technical expertise on HVAC systems during inspections.

• - Collaborate with project teams on HVAC design for new sterile facilities or upgrades.
• Review HVAC drawings, P&IDs, and control strategies to ensure alignment with cleanroom design and classification.
• Support installation, commissioning, and qualification of HVAC systems in sterile manufacturing areas.

• - Analyze environmental monitoring trends and HVAC performance data to proactively identify and resolve deviations.
• Ensure timely investigation and CAPA implementation for HVAC-related non-conformances or out-of-spec environmental conditions.

• - Develop, review, and maintain SOPs related to HVAC operation, maintenance, and monitoring.
• Ensure proper documentation of maintenance activities and change control in compliance with GMP.

• - Mentor and train junior HVAC engineers/technicians.
• Promote best practices and GMP-compliant behavior in HVAC operations and maintenance teams.

• Bachelors degree in mechanical engineering, HVAC Engineering, or related field.
• Minimum 35 years of experience in HVAC systems in GMP-compliant sterile pharmaceutical environments.
• Strong knowledge of cleanroom HVAC design, pressure cascade, laminar flow, BMS systems, and HEPA filtration.
• Experience with environmental monitoring requirements and data analysis.
• Proven participation in regulatory audits (USFDA, EMA, MHRA, etc.).
• Familiarity with HVAC system automation and Building Management Systems (BMS).

• In-depth understanding of cGMP, EU GMP Annex 1, and relevant global pharmaceutical guidelines.
• Strong analytical and problem-solving skills.
• Excellent communication, documentation, and teamwork abilities.
• Ability to work under pressure in a highly regulated environment.

• Certified Energy Manager (CEM) or similar HVAC-related certification.
• GMP / HVAC design and compliance training from recognized bodies.