Lead Validation Specialist

Job Description

Job Description

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

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.