CQV Validation Engineer - Utilities & Facilities

Veg Group; Puerto Rico; On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. in the United States seeks two experienced Validation Engineers (mid-level to senior) with strong CQV expertise in utilities and facilities to support commissioning, qualification, and validation activities in a regulated environment.

You will develop and execute CQV documentation (IQ/OQ/PQ), lead qualification for steam, HVAC, purified water, and other utility systems, and coordinate with Engineering, Quality, and Operations to meet project milestones.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Mid-Level: 3–5+ years of CQV experience in regulated industries (pharma, biotech, medical devices).
• Senior Level: 6+ years of CQV experience with demonstrated leadership in qualification activities.
• Strong hands-on experience with utilities and facility systems (steam, HVAC, purified water, electrical distribution, compressed air, etc.).
• In-depth knowledge of GMP, FDA regulations, and industry standards.
• Experience writing and executing qualification protocols.
• Excellent problem-solving and troubleshooting skills.
• Strong communication and collaboration abilities.

Responsibilities

• Develop, review, and execute commissioning and qualification (CQV) documentation, including protocols and reports (IQ/OQ/PQ).
• Lead and support qualification activities for utility and facility systems such as steam, HVAC, purified water, process utilities, electrical distribution, and compressed air.
• Coordinate with cross-functional teams including Engineering, Quality, and Operations to ensure project milestones are met.
• Perform field execution of protocols, ensuring compliance with GMP and company procedures.
• Identify, investigate, and resolve complex technical issues during qualification and startup activities.
• Ensure all documentation is accurate, complete, and aligned with regulatory and client standards.
• Support deviation investigations, CAPAs, and change control processes as needed.

Skills

CQV experience

GMP compliance

Problem-solving

Communication

Regulatory knowledge

Education

Bachelor’s degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. in the United States seeks two experienced Validation Engineers (mid-level to senior) with strong CQV expertise in utilities and facilities to support commissioning, qualification, and validation activities in a regulated environment.

You will develop and execute CQV documentation (IQ/OQ/PQ), lead qualification for steam, HVAC, purified water, and other utility systems, and coordinate with Engineering, Quality, and Operations to meet project milestones.