Lead Validation Specialist
Listed on 2026-01-13
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Position: Lead Validation Specialist
Type: Direct hire, full‑time, permanent (no sponsorship, 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.
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
- 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
- Mid‑Senior level
- Full‑time
- Quality Assurance
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.
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