HVAC Validation Specialist for GMP Environments

Pinnaql, Inc.; Aguadilla (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

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

You will develop IQ/OQ protocols, coordinate testing with the BMS team, review specifications and commissioning evidence, and ensure compliance with GMP, GDP, and regulatory guidance while maintaining clear documentation.

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, FDA cGMP requirements and ISPE/GAMP principles.
• Ability to interpret User Requirements Specifications, design documents and commissioning evidence.
• Strong written and verbal communication in English; Spanish preferred for site interaction.

Responsibilities

• Review User Requirements, design documents, drawings, vendor manuals, commissioning records and other lifecycle documents.
• Confirm qualification boundary, components, test strategy and acceptance criteria.
• Perform field walkdowns and document reviews to confirm readiness for qualification.
• Generate IQ/OQ protocol using company procedures and templates.
• Incorporate review comments and support routing until protocol approval.
• Execute approved IQ/OQ protocol in line with GDP/GMP practices.
• Document discrepancies and deviations and provide technical information for resolution.
• Coordinate retesting after corrective actions within scope and hours.
• Assemble executed protocol and evidence for review and approval.
• Maintain Requirements Traceability Matrix linking requirements to tests and evidence.
• Generate Qualification Summary Report describing scope, results, deviations and conclusions.
• Support resolution of review comments and final approvals for all documents.
• Maintain weekly forecast, deliverable tracker and time records.

Skills

Qualification protocols

CSV lifecycle

GxP environments

English proficiency

Education

Bachelor's degree in Engineering or related field

Job description

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

You will develop IQ/OQ protocols, coordinate testing with the BMS team, review specifications and commissioning evidence, and ensure compliance with GMP, GDP, and regulatory guidance while maintaining clear documentation.