HVAC Qualification Lead: GMP/CSV for Biopharma

Validation & Engineering Group, Inc.; Isabela N00207-Air Base (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

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

The role covers IQ/OQ protocol development, field walkdowns, calibration reviews, and coordination with BMS resources to ensure compliant, validated equipment. Strong documentation, GMP knowledge, and clear English communication are essential.

Qualifications

• Demonstrated ability to write qualification or validation documents and reports.
• Experience developing and executing qualification protocols or CSV lifecycle documents.
• Knowledge of GMP, GDP, cGMP, and data integrity principles.

Responsibilities

• Lead IQ/OQ protocol development and execution per company procedures.
• Review design documents, risk assessments, and commissioning evidence for qualification.
• Coordinate testing with BMS resources and manage deviations and discrepancies.
• Assemble final qualification package including TRACE matrices and summaries.

Skills

Qualification protocols

CSV lifecycle

Pharma GMP knowledge

Regulatory guidance

Data integrity

Risk-based qualification

FDA cGMP

21 CFR Part 11

Written communication

English proficiency

Spanish preferred

Education

Bachelor's degree in Engineering or related field

Job description

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

The role covers IQ/OQ protocol development, field walkdowns, calibration reviews, and coordination with BMS resources to ensure compliant, validated equipment. Strong documentation, GMP knowledge, and clear English communication are essential.