CQV Lead - Utilities & Facilities Qualification

Echo-Consulting-Group; Manatí (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

ECHO Consulting Group, Inc. is seeking a detail-oriented Utilities & Facilities Qualification Engineer to support commissioning, qualification, and validation activities in a regulated pharmaceutical manufacturing environment.

The successful candidate will plan, execute, and document qualification activities for critical utilities, facility systems, and associated equipment while ensuring compliance with current Good Manufacturing Practices (cGMP), approved procedures, and applicable

Qualifications

• Strong technical writing and documentation skills.
• Knowledge of cGMP regulations and validation lifecycle.
• Experience supporting IQ/OQ/PQ execution or validation documentation.
• Familiar with risk-based qualification principles and documentation best practices.

Responsibilities

• Develop, review, and execute commissioning and qualification protocols (DQ/IQ/OQ/PQ).
• Support qualification of critical utility systems (HVAC, water systems, electrical, gases, BMS).
• Support facility qualification for manufacturing areas, labs, cleanrooms, warehouses, controlled environments.
• Prepare URS, risk assessments, traceability matrices, test scripts, qualification reports, turnover packages.

Skills

Technical writing

Documentation

Regulatory compliance

Quality assurance

Education

Bachelor's degree in Engineering, Chemistry, Microbiology, Biology, or related scientific discipline

Job description

ECHO Consulting Group, Inc. is seeking a detail-oriented Utilities & Facilities Qualification Engineer to support commissioning, qualification, and validation activities in a regulated pharmaceutical manufacturing environment.

The successful candidate will plan, execute, and document qualification activities for critical utilities, facility systems, and associated equipment while ensuring compliance with current Good Manufacturing Practices (cGMP), approved procedures, and applicable