HVAC Qualification Engineer for GMP/CSV (Pharma)

Veg Group; Aguadilla (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

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

You will coordinate IQ/OQ protocols, review balancing reports, and ensure compliance with GMP and GDP standards. The ideal candidate holds a Bachelor's degree in Engineering or related field, has experience developing qualification protocols for CSV environments, and demonstrates strong English

Qualifications

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

Responsibilities

• Verify installed air handling units, fans, cooling components, filters, ductwork, HEPA filters, dampers, instruments, and identified system components against approved documents.
• Verify calibration status and identification of critical temperature, RH, pressure, airflow, and related instruments.
• Test operating sequences, alarms, interlocks, and setpoints; manage recovery after challenge conditions.
• Review room pressure relationships, airflow, temperature, RH, and air-change performance per approved requirements.
• Coordinate qualification testing with the BMS resource where HVAC controls, alarms, or trends are executed through the BMS.
• Generate an IQ/OQ protocol using current company procedures and templates.
• Execute approved IQ/OQ protocol and document discrepancies and deviations.
• Assemble protocol and evidence into a complete package for review and approval.
• Maintain weekly forecast, deliverable tracker, and time records.

Skills

Written and verbal communication

English proficiency

Spanish preferred

Education

Bachelor's degree in Engineering or related field

Job description

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

You will coordinate IQ/OQ protocols, review balancing reports, and ensure compliance with GMP and GDP standards. The ideal candidate holds a Bachelor's degree in Engineering or related field, has experience developing qualification protocols for CSV environments, and demonstrates strong English