Pharma HVAC Qualification Specialist

Validation & Engineering Group, Inc.; Aguadilla, Isabela (PR, PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking an HVAC Qualification Specialist to lead qualification activities for air handling and environmental control systems in controlled manufacturing areas.

You will verify installation, calibration, and test sequences, and generate IQ/OQ protocols under GMP/compliance expectations. You will coordinate with BMS resources, review balancing reports and commissioning evidence, and maintain complete documentation including Qualification Summary Reports.

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Working knowledge of GMP regulations, GDP, regulatory guidance, data integrity, risk-based qualification and validation, and ISPE/GAMP principles.

Responsibilities

• Verify installed HVAC components against approved documents.
• Verify calibration status of critical temperature, RH, pressure, and related instruments.
• Test operating sequences, alarms, interlocks, setpoints, and recovery procedures.
• Review room pressure relationships, airflow, temperature, and controlled environmental parameters.
• Generate IQ/OQ protocols and support their approval and execution.
• Coordinate retesting after corrective actions and assemble the qualification package.

Skills

Communication skills

English proficiency

Spanish proficiency

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. is seeking an HVAC Qualification Specialist to lead qualification activities for air handling and environmental control systems in controlled manufacturing areas.

You will verify installation, calibration, and test sequences, and generate IQ/OQ protocols under GMP/compliance expectations. You will coordinate with BMS resources, review balancing reports and commissioning evidence, and maintain complete documentation including Qualification Summary Reports.