Validation Specialist – Utilities & Facilities

Validation Specialist – Utilities & Facilities

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. Excited to build something meaningful together? We look forward to hearing from you.

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.