Lead Validation Specialist

Mundelein, IL 60060

Employment Type: Permanent Job Category: Validation Job Number: 53685174 Compensation: $130000-150000 / year

Job Description

Position: Lead Validation Specialist
Type: This is a direct hire, Full-Time, permanent position. 
Sponsorship is NOT available currently, NO C2C or third party representation
Location: Mundelein, IL 60060 (regional travel as projects require) onsite daily

Salary Range $130K - $150K + Benefits

I am looking for a Lead Validation Specialist that can support commissioning, qualification, and validation (C&Q) initiatives across facilities, utilities, equipment, and automated systems.

This is a hands-on senior contributor 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
  • Perform 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 (VS-I / VS-II) 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
  • Strong working knowledge of FDA regulations, cGMP, and GAMP
  • Experience reviewing P&IDs, wiring diagrams, HVAC/mechanical drawings, and specifications
  • 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.

Meet Your Recruiter

Mary Gallian

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. 

 As one of the most respected names in engineering staffing, Sterling has hundreds of opportunities with top employers. If you’ve got a friend or colleague seeking their next move in engineering, we could have their next opportunity. We offer a referral bonus for every referral that we place. Submit referral now. 

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About Mundelein, IL

Ready to take the next step in your career? Explore exciting job opportunities in and around Mundelein, Illinois! Nestled in Lake County, Mundelein offers a perfect blend of suburban charm and urban opportunities for job seekers. With its proximity to Chicago, professionals can enjoy a thriving job market while savoring the tranquility of the area's parks like Diamond Lake and the picturesque Independence Grove Forest Preserve. Discover a vibrant cultural scene with the nearby Wirtz Gallery and the historic Tighthead Brewing Co., or catch a show at the James Lumber Center for the Performing Arts. Mundelein is also a foodie's paradise with a variety of dining options ranging from classic American diners to international flavors. Join us in Mundelein, where career growth and a high quality of life meet!