BMS Qualification Specialist (GxP & CSV)

Validation & Engineering Group, Inc.; Aguadilla (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. (VEG), a Pinnaql company, seeks a Building Management System Qualification Specialist to lead qualification of BMS functions used in monitored facility systems.

The role requires applying company procedures to the defined system boundary and coordinating with HVAC and Facilities teams. The ideal candidate will review design documents, vendor manuals, and validation records; generate IQ/OQ protocols; execute tests per GDP/21 CFR 11 standards; document

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, regulatory guidance, data integrity principles, risk-based qualification and validation, and FDA cGMP requirements (and ISPE/GAMP).
• Ability to interpret User Requirements, design documents, drawings, and commissioning evidence.
• Ability to write clear qualification or validation documents and reports and to execute testing accurately.

Responsibilities

• Lead qualification of Building Management System functions used to monitor or control qualified facility systems.
• Verify configurations, servers, workstations, controllers, licenses, and interfaces against approved records.
• Coordinate integrated testing with HVAC and Facilities qualification resources to ensure complete coverage.
• Generate IQ/OQ protocols and manage review comments to protocol approval and execution.
• Document discrepancies, deviations, and retesting needs with technical rationale for resolution.
• Assemble executed protocols and evidence into a complete package for review and approval.
• Maintain weekly forecast, deliverable tracker, and time record for assigned work.

Skills

Qualification protocols

CSV lifecycle

GxP environment

Regulatory knowledge

Documentation writing

Communication (English)

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. (VEG), a Pinnaql company, seeks a Building Management System Qualification Specialist to lead qualification of BMS functions used in monitored facility systems.

The role requires applying company procedures to the defined system boundary and coordinating with HVAC and Facilities teams. The ideal candidate will review design documents, vendor manuals, and validation records; generate IQ/OQ protocols; execute tests per GDP/21 CFR 11 standards; document