BMS Validation Engineer – GMP/CSV Focus

Veg Group; Aguadilla (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

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

You will apply company procedures to develop IQ/OQ protocols, review lifecycle documents, and ensure traceability across qualification artifacts. The role requires strong English communication and experience with validated systems in pharmaceutical environments, coordinating with HVAC and facilities teams to ensure complete coverage

Qualifications

• Bachelor's degree in Engineering or related field.
• Hands-on experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or GxP environments.
• Working knowledge of GMP regulations, GDP, FDA 21 CFR Part 11, ISPE/GAMP principles.
• Ability to interpret specifications, design docs, and commissioning evidence.
• Strong written and verbal communication in English; Spanish proficiency preferred.

Responsabilités

• Review User Requirements, design documents, drawings, vendor manuals, commissioning records, calibration records, and risk assessments to define scope.
• Confirm qualification boundary, system components, prerequisites, test strategy, and acceptance criteria.
• Perform field walkdowns and document reviews to confirm readiness for qualification.
• Generate IQ/OQ protocols per company procedures and routing process.
• Coordinate and execute approved IQ/OQ protocols and maintain documentation.
• Document discrepancies and deviations with technical information for resolution.
• Coordinate retesting after corrective actions within scope and hours.
• Assemble executed protocol and evidence into a complete review package.
• Generate Requirement Traceability Matrix linking requirements to tests and evidence.
• Create Qualification Summary Report describing scope, results, deviations, and conclusions.
• Maintain weekly forecast, deliverable tracker, and time records.

Connaissances

Communication skills

English proficiency

Spanish proficiency (preferred)

Formation

Bachelor's degree in Engineering

Description du poste

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

You will apply company procedures to develop IQ/OQ protocols, review lifecycle documents, and ensure traceability across qualification artifacts. The role requires strong English communication and experience with validated systems in pharmaceutical environments, coordinating with HVAC and facilities teams to ensure complete coverage