Senior Validation Specialist

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This range is provided by Sterling Engineering. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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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

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.

• 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

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.

Mid‑Senior level

Full-time

Quality Assurance, Engineering, and Analyst

Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Engineering Services