Job Description
Validation Engineer
Belvidere, IL | ?Up to $100K | Employee-Owned Company
(DIRECT HIRE)
No Visa Transfers nor Visa Sponsorship
Join a growing automation manufacturer where your work directly impacts the medical device and advanced manufacturing industries.
Our client is a 100% employee-owned engineering company specializing in the design and build of custom high-speed automation assembly systems used in medical device, consumer goods, and industrial manufacturing environments. They are seeking a hands-on Validation Engineer to support commissioning, qualification, and technical documentation efforts for complex automated machinery.
This is a fully onsite opportunity in Belvidere, IL with occasional travel to the South Elgin facility as needed.
What You’ll Be Doing
- Develop and execute DQ/IQ/OQ/PQ validation protocols in compliance with cGMP standards
- Support FAT and SAT commissioning & qualification activities with customers
- Create and maintain technical documentation including:
- Functional Design Specifications
- Software & Hardware Design Specs
- Configuration & Vision Specs
- Technical Manuals & Operator Guides
- Machine Instructions & Spare Parts Documentation
- Execute machine test cases to verify functionality and quality performance
- Update validation documentation in Kneat Gx
- Conduct risk assessments and FMEA activities
- Support CE technical construction file development
What They’re Looking For
- 2-year technical degree in engineering or related field
- 3+ years of experience writing technical documentation in manufacturing environments
- Experience with validation protocols and commissioning activities
- Ability to read blueprints and develop technical documents
- Experience with cGMP environments preferred
- LEAN, Six Sigma, ISO, or medical device experience is a plus
Why This Opportunity Stands Out
- Employee Stock Ownership Program (ESOP)
- Pension Plan + 401(k) Contribution
- Excellent medical benefits
- Employer-paid dental, vision, disability & life insurance
- Tuition reimbursement
- Wellness reimbursement
- Stable, growing organization with cutting-edge automation projects
- Flexible Friday schedule (half days!)
? Schedule: Monday–Thursday 7AM–4PM | Friday 7AM–12PM
? Compensation: $72K–$100K depending on experience
? Compensation: $72K–$100K depending on experience
Screening Questions
- Do you have experience writing and executing DQ/IQ/OQ/PQ validation protocols in a cGMP environment?
- Have you participated in FAT and SAT activities for manufacturing equipment?
- Do you have experience creating technical documentation such as FDS, SDS, HDS, validation protocols, or operator manuals?
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 | South Elgin, IL |
| Industry | Staffing/Employment Agencies |
| Salary | $72,000–$100,000 Per Year |
| 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
- Assembly Equipmentunmatched
- Automationunmatched
- Blueprintsunmatched
- Commissioningunmatched
- Commissioning - Engineeringunmatched
- Construction Supportunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Disability Insuranceunmatched
- Documentationunmatched
- Failure Mode and Effects Analysis (FMEA)unmatched
- Functional Testingunmatched
- Hardware Designunmatched
- Hardware Specificationunmatched
- ISO (International Organization for Standardization)unmatched
- Lean Six Sigmaunmatched
- Life Insuranceunmatched
- Manufacturingunmatched
- Manufacturing Equipmentunmatched
- Medical Equipmentunmatched
- Process Validationunmatched
- Regulatory Complianceunmatched
- Reimbursementunmatched
- Requirements Managementunmatched
- Risk Analysisunmatched
- Software Designunmatched
- Technical Supportunmatched
- Technical Writingunmatched
- Technical/Engineering Designunmatched
- Test Caseunmatched
- Validation Documentationunmatched
- Validation Planunmatched
- Willing to Travelunmatched
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