Validation Specialist � Utilities & Facilities

Pinnaql • Guaynabo, PR

1d

About The Position

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.

Requirements

• 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.

Nice To Haves

• Experience working in capital projects or startup environments.
• Familiarity with validation lifecycle and risk-based approaches.
• Prior client-facing experience is a plus.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level