BMS Qualification Engineer — GMP Validation & CSV

Pinnaql, Inc.; Aguadilla (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Building Management System Qualification Specialist to lead qualification activities for monitored or controlled systems.

You will verify equipment, software, security, and data integrity, coordinating with HVAC and Facilities teams to ensure complete coverage and compliant documentation. Responsibilities include IQ/OQ protocol generation, execution, deviations handling, and compiling final qualification artifacts, including

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience supporting qualification/CSV work in pharmaceutical or GxP environments.
• Knowledge of GMP, GDP, FDA 21 CFR Part 11, ISPE/GAMP.
• Ability to write qualification or validation documents and reports.
• Strong written and verbal communication; Spanish proficiency preferred.

Responsibilities

• Review User Requirements Specifications, design documents, drawings, vendor manuals, commissioning records, calibration records and other lifecycle documents.
• Confirm qualification boundary, components, prerequisites, test strategy, criteria and documentation for protocols.
• Perform field walkdowns and documentation to ensure readiness for qualification.
• Generate IQ/OQ protocol using the company procedures and document control process.
• Incorporate review comments and support protocol routing until approval for execution.
• Execute the IQ/OQ protocol in accordance with GDP and company procedures.
• Document discrepancies and deviations and provide information for assessment and resolution.
• Coordinate retesting after corrective actions within scope and approved hours.
• Assemble executed protocol and evidence into a complete package for review.
• Generate and maintain Requirements Traceability Matrix and Qualification Summary Report.
• Support review comment resolution and final approvals.
• Maintain weekly forecast, deliverable tracker, and time record for the work.

Skills

Communication skills

English proficiency

Documentation writing

Interpret requirements

Education

Bachelor's degree in Engineering

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Building Management System Qualification Specialist to lead qualification activities for monitored or controlled systems.

You will verify equipment, software, security, and data integrity, coordinating with HVAC and Facilities teams to ensure complete coverage and compliant documentation. Responsibilities include IQ/OQ protocol generation, execution, deviations handling, and compiling final qualification artifacts, including