HVAC Validation Engineer — GMP/CSV Focus

Veg Group; Aguadilla (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. is a leading provider offering qualification and validation services across pharmaceutical, biotech, chemical, and medical device industries. The HVAC specialist will lead IQ/OQ activities for air handling systems and contribute to risk-based validation strategies.

The role requires reviewing regulatory documentation, executing IQ/OQ protocols, and producing qualification summaries. English proficiency is essential; Spanish is a plus.

Qualifications

• Bachelor's degree in Engineering or related field.
• Hands-on experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience in pharma/GxP environments.
• Knowledge of GMP, GDP, data integrity, and FDA cGMP/regulatory guidance.
• Ability to interpret user requirements and draft qualification reports.

Responsibilities

• Lead qualification activities for air handling and environmental control systems in controlled spaces.
• Verify components, sensors, and calibration statuses against approved docs.
• Develop IQ/OQ protocols and manage approvals.
• Coordinate testing with BMS resources and document evidence.
• Assemble complete qualification packages and maintain traceability matrices.
• Maintain weekly forecast and time records.
• Support final review and approval of qualification documents and reports.

Skills

English proficiency

Spanish proficiency

Education

Bachelor's degree in Engineering or related field

Experience developing and executing qualification protocols or CSV lifecycle documents

Experience in pharmaceutical, biologics, or GxP environments

Knowledge of GMP, GDP, data integrity and FDA cGMP requirements

Ability to interpret specifications and draft qualification documents

Job description

Validation & Engineering Group, Inc. is a leading provider offering qualification and validation services across pharmaceutical, biotech, chemical, and medical device industries. The HVAC specialist will lead IQ/OQ activities for air handling systems and contribute to risk-based validation strategies.

The role requires reviewing regulatory documentation, executing IQ/OQ protocols, and producing qualification summaries. English proficiency is essential; Spanish is a plus.