BMS Qualification Engineer – GMP/CSV Specialist

Veg Group; Aguadilla (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Building Management System Qualification Specialist to lead qualification activities for monitored facility systems.

You will verify hardware, software, interfaces, and data integrity while coordinating with HVAC and Facilities teams to ensure comprehensive coverage. The role requires executing IQ/OQ protocols, documenting deviations, and delivering complete qualification packages.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience developing and executing qualification protocols or CSV lifecycle tests.
• Experience in pharmaceutical/biologics GxP environments.
• Knowledge of GMP, GDP, 21 CFR Part 11, and ISPE/GAMP principles.
• Ability to interpret URS/design documents/vendor documentation.
• Strong written and verbal English; Spanish proficiency preferred.

Responsibilities

• Review URS, design documents, drawings, vendor manuals, commissioning records, calibration records and other lifecycle documents.
• Confirm qualification boundary, components, prerequisites, test strategy and acceptance criteria.
• Perform field walkdowns and document reviews to confirm readiness for qualification.
• Generate IQ/OQ protocol using company templates and control processes.
• Incorporate review comments and support protocol routing until approval.
• Execute IQ/OQ per procedures and GDP; document discrepancies and deviations.
• Coordinate retesting after approved corrective actions within scope.
• Assemble executed protocol and supporting evidence for approval.
• Generate and maintain Requirements Traceability Matrix linking requirements to tests.
• Generate Qualification Summary Report describing scope, results, deviations, open items, conclusions.
• Maintain weekly forecast, deliverable tracker and time records.

Skills

Communication skills

English proficiency

GxP knowledge

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. seeks a Building Management System Qualification Specialist to lead qualification activities for monitored facility systems.

You will verify hardware, software, interfaces, and data integrity while coordinating with HVAC and Facilities teams to ensure comprehensive coverage. The role requires executing IQ/OQ protocols, documenting deviations, and delivering complete qualification packages.