Senior Validation Specialist jobs in United States
cer-icon
Apply on Employer Site
company-logo

Sterling Engineering · 1 day ago

Senior Validation Specialist

positionMundelein, IL
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
money$110K/yr - $140K/yr
date5+ years exp

Sterling Engineering is seeking a Lead Validation Specialist who can support commissioning, qualification, and validation initiatives across various facilities and systems. This hands-on senior contributor role involves leading validation strategies, interfacing with clients and auditors, and mentoring junior specialists.

ConsultingInformation Technology
check
Growth OpportunitiesbadNo H1Bnote
Hiring Manager
Mary Gallian
linkedin

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

Qualification

FDA regulationsCGMPGAMPTechnical writingProject managementClient-facing skillsProblem resolutionCommunication skills

Required

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

Company

Sterling Engineering

twittertwittertwitter
company-logo
Sterling Engineering is an engineering company providing technical recruitment and engineering project services.
dateFounded in 1969
location
Westchester, Illinois, USA
people-size501-1000 employees
web-link
http://sterling-engineering.com

Funding

Current Stage
Late Stage

Leadership Team

leader-logo
Dolores Connolly
CEO
linkedin

Recent News

Hartford Business Journal
With World War II-era roots, Barkhamsted machine shop Sterling Engineering aims to double in size amid broader turnaround effort
2025-01-28
Hartford Business Journal
Barkhamsted engineering group lands $33M component contract for Sikorsky
2024-12-20
Business Wire
Air Industries Group Subsidiary Sterling Engineering Corporation Receives $3.2M in New Contracts
2024-01-03
Company data provided by crunchbase