Senior Specialist - HVAC (Sterile)

• 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.

• Bachelor's degree in mechanical engineering, HVAC Engineering, or related field.
• Minimum 3-5 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.

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