Lead Validation Specialist

Type: Contract to hire (12+ months), no sponsorship available. Onsite daily in Mundelein, IL 60060 with regional travel as projects require. Pay rate: $55.00 - $65.00 per hour.

About the Role

We are seeking a hands-on Lead Validation Specialist from the food, biotechnology, or pharmaceutical industry to support commissioning, qualification, and validation (C&Q) initiatives across facilities, utilities, equipment, and automated systems. This senior role involves owning validation strategy, interfacing with clients and auditors, and mentoring junior validation specialists.

Responsibilities

• Lead and execute IQ/OQ/PQ activities for facilities, utilities, equipment, control systems, and HVAC.
• Conduct cGMP audits, gap assessments, and impact analyses to scope validation work.
• Develop system specifications aligned with GAMP and Good Engineering Practices (GEP).
• Author and manage Commissioning & Validation Master Plans (CVMPs).
• Coordinate with OEMs, construction managers, contractors, and end users during commissioning and qualification.
• Build and maintain Traceability Matrices (UR/FS/DS → IQ/OQ/PQ).
• Author Summary Reports and defend validation outcomes during audits and inspections.
• Lead validation staff and support their professional development.
• Manage multiple projects simultaneously, balancing scope, schedule, and quality.

Requirements

• Bachelor’s degree in Engineering, Science, or Technical discipline with 5-7 years in an FDA-regulated environment OR an Associate degree, military, or technician background with 7-10 years in a regulated industry.
• Working knowledge of FDA regulations, cGMP, and GAMP.
• Experience in the food, pharma, or biotech industry.
• Experience reviewing P&IDs, wiring diagrams, HVAC/mechanical drawings, and specifications.
• Hands-on experience as a Validation Engineer or equivalent role.
• Comfortable using field measurement and verification instrumentation.
• Excellent technical writing, communication, and client-facing skills.
• Proven ability to manage scope, change control, and problem resolution.