Position: Lead Validation Specialist
Type: Contract to hire, no sponsorship available currently, NO third party representation

Duration: 12+ months contract to hire
Location: Mundelein, IL 60060 (regional travel as projects require) onsite daily

Pay rate $55.00 - $65.00 per hour - must be able to accept a permanent position

I am looking for a Lead Validation Specialist coming from the food, biotechnology or pharmaceutical industry that can support commissioning, qualification, and validation (C&Q) initiatives across facilities, utilities, equipment, and automated systems.

This is a hands-on senior validation specialist role with leadership responsibility—ideal for someone who enjoys owning validation strategy, interfacing with clients and auditors, and mentoring junior validation specialists.

OVERVIEW OF 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

QUALIFICATIONS
•    Bachelor’s degree in Engineering, Science, or Technical discipline with 5–7 years in an FDA-regulated environment
 OR
an Associate degree / military / technician background with 7–10 years regulated industry experience
•    Must have working knowledge of FDA regulations, cGMP, and GAMP - Food, Pharma or Biotech industry experience
•    Experience reviewing P&IDs, wiring diagrams, HVAC/mechanical drawings, and specifications

must have experience as a Validation Engineer or
•    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