Validation Specialist � 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

Current job opportunities are posted here as they become available.

Validation Specialist – Utilities & Facilities

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Specialist – Utilities & Facilities

Position Summary:
We are seeking two experienced Validation Engineers (mid-level to senior) with strong expertise in utilities and facilities systems to support commissioning, qualification, and validation activities within a regulated environment. The ideal candidates will have hands-on experience with critical utility systems and a proven ability to develop and execute qualification documentation while troubleshooting and resolving complex technical issues.

Key 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.

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.

Preferred Qualifications:

Experience working in capital projects or startup environments.

Familiarity with validation lifecycle and risk-based approaches.

Prior client-facing experience is a plus.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.