HVAC Qualification Specialist: Validation Engineer in Pharma

Pinnaql, Inc.; Aguadilla (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an HVAC Qualification Specialist to lead qualification activities for air handling and environmental control systems in controlled manufacturing areas.

You will review documents, generate IQ/OQ protocols, and coordinate testing across the project lifecycle. The role emphasizes risk-based validation, adherence to GDP/GMP, and writing clear qualification reports.

Qualifications

• Bachelor's degree in Engineering or related field required.
• Experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience in pharmaceutical/biologics GxP environments preferred.
• Familiarity with GMP, GDP, FDA cGMP, and EU GMP is desirable.
• Ability to interpret specs, drawings, and vendor docs; write clear reports.

Responsibilities

• Lead qualification activities for air handling and environmental control systems.
• Verify installed components and calibration status against documents.
• Test operating sequences, alarms, setpoints, and recovery under challenge conditions.
• Review balancing reports, HEPA tests, and cleanroom classifications for leverage.
• Coordinate IQ/OQ protocol development and execution per procedures.
• Document discrepancies and deviations; support retesting after actions.
• Assemble protocol packages and traceability matrices for review.

Skills

Technical writing

GxP awareness

Regulatory compliance

Quality systems

English communication

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an HVAC Qualification Specialist to lead qualification activities for air handling and environmental control systems in controlled manufacturing areas.

You will review documents, generate IQ/OQ protocols, and coordinate testing across the project lifecycle. The role emphasizes risk-based validation, adherence to GDP/GMP, and writing clear qualification reports.