BMS Qualification Lead for GMP/CSV Programs

Pinnaql, Inc.; Aguadilla (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Building Management System Qualification Specialist to lead BMS qualification activities across pharmaceutical environments.

The role requires drafting IQ/OQ protocols, reviewing lifecycle documents, coordinating with HVAC and Facilities teams, and ensuring GMP, GDP, and 21 CFR Part 11 compliance. Strong English is required; Spanish is a plus.

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience drafting and executing qualification protocols or CSV documentation.
• Experience in GMP/GxP environments with FDA cGMP.

Responsibilities

• Review lifecycle documents and determine qualification boundaries and acceptance criteria.
• Generate IQ/OQ protocols and incorporate reviewer comments.
• Execute IQ/OQ per company procedures and GDP.
• Maintain evidence packages and traceability matrices.
• Coordinate retesting and weekly forecasts.

Skills

Written and verbal communication

English proficiency

Spanish proficiency

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. is seeking a Building Management System Qualification Specialist to lead BMS qualification activities across pharmaceutical environments.

The role requires drafting IQ/OQ protocols, reviewing lifecycle documents, coordinating with HVAC and Facilities teams, and ensuring GMP, GDP, and 21 CFR Part 11 compliance. Strong English is required; Spanish is a plus.