Validation Engineer-Belvedere

Job Description

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

Screening Questions

1. Do you have experience writing and executing DQ/IQ/OQ/PQ validation protocols in a cGMP environment?
2. Have you participated in FAT and SAT activities for manufacturing equipment?
3. 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.