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.
Numbers & Facts
| Location | Mundelein, IL |
| Industry | Staffing/Employment Agencies |
| Salary | $55–$65 Per Hour |
| Company Size | 500 to 999 employees |
| Year Founded | 1969 |
| Website | http://www.sterling-engineering.com |
About Company
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.
Skills
- Analysis Skillsunmatched
- Auditingunmatched
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Change Managementunmatched
- Commissioningunmatched
- Constructionunmatched
- Consultingunmatched
- Control Systemsunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Customer Relationsunmatched
- Electrical Wiringunmatched
- FDA (Food and Drug Administration)unmatched
- FDA Requirementsunmatched
- GEP (Good Engineering Practices)unmatched
- HVACunmatched
- Instrumentationunmatched
- Leadershipunmatched
- Mentoringunmatched
- Militaryunmatched
- Multitaskingunmatched
- OEM (Original Equipment Manufacturer)unmatched
- Problem Solving Skillsunmatched
- Process Validationunmatched
- Project/Program Managementunmatched
- Reporting Skillsunmatched
- Technical Writingunmatched
- Traceabilityunmatched
- Validation Planunmatched
- Willing to Travelunmatched
- Writing Skillsunmatched
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