HVAC Qualification Specialist

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

Current job opportunities are posted here as they become available.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• HVAC Qualification Specialist

The HVAC resource will lead qualification activities for air handling and environmental control systems serving classified or controlled manufacturing areas. The final boundary and test list will be established from approved requirements and risk assessments.

Expected activities include the following as applicable:

• Verify installed air handling units, fans, cooling components, filters, ductwork, terminal HEPA filters, dampers, instruments, and identified system components against approved documents.
• Verify calibration status and identification of critical temperature, relative humidity, pressure, airflow, and related instruments.
• Test operating sequences, start and stop functions, alarms, interlocks, setpoints, monitoring points, and recovery following applicable challenge conditions.
• Verify room pressure relationships, airflow direction, temperature, relative humidity, air change or airflow performance, and other controlled environmental parameters defined in approved requirements.
• Review and reference approved balancing reports, HEPA integrity test reports, airflow visualization studies, cleanroom classification reports, and commissioning evidence when approved for leverage.
• Coordinate qualification testing with the BMS resource where HVAC controls, alarms, or trends are executed through the BMS.

Scope of Work:

The assigned qualification resource shall perform the following activities for each system or equipment item included in the approved assignment:

• Review the applicable User Requirements Specification, design documents, drawings, vendor manuals, commissioning records, calibration records, certificates, approved risk assessments, and other available lifecycle documents.
• Confirm the qualification boundary, system components, prerequisites, test strategy, acceptance criteria, and documentation needed to support protocol development and execution.
• Perform field walkdowns and document reviews needed to confirm that the system is ready for qualification.
• Generate an IQ/OQ protocol using the current Company procedure, template, and document control process.
• Incorporate review comments and support protocol routing until the protocol is approved for execution.
• Execute the approved IQ/OQ protocol in accordance with the Company procedures and Good Documentation Practices.
• Document discrepancies, exceptions, and deviations identified during execution and provide the technical information needed for assessment and resolution.
• Coordinate retesting after approved corrective actions when retesting is within the assigned scope and authorized hours.
• Assemble the executed protocol and supporting evidence into a complete package suitable for review and approval.
• Generate and maintain the Requirements Traceability Matrix linking applicable requirements to qualification tests and objective evidence.
• Generate the Qualification Summary Report describing the scope performed, results, deviations, open items, and conclusion on system qualification status.
• Support review comment resolution and final approval of the executed protocol, Requirements Traceability Matrix, and Qualification Summary Report.
• Maintain an accurate weekly forecast, deliverable tracker, and time record for the assigned work.

Qualifications:

• Bachelor's degree in Engineering or related field.
• Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests for the specific service area proposed.
• Prior experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Working knowledge of applicable GMP regulations, Good Documentation Practices (GDP), regulatory guidance, data integrity principles, risk-based qualification and validation, and industry standards relevant to the assigned scope, including FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles.
• Ability to interpret User Requirements Specifications, design documents, drawings, functional specifications, control narratives, vendor documentation, calibration records, and commissioning evidence.
• Demonstrated ability to write clear qualification or validation documents and reports and to execute testing accurately in the applicable field or computerized environment.
• Strong written and verbal communication skills in English. Spanish proficiency is preferred for effective site interaction.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.