Validation Engineer

Validation Engineer Responsibilities

• Develop documentation and execute test cases for DQ/IQ/OQ/PQ protocols complying with cGMP
• Absorb and execute test cases for FAT and SAT C&Q activities with customers
• Collaborate with internal and external team members to write documentation including Functional Design Specifications, Software Design Specs, Hardware Design Specs, Configuration Specs, Vision Design Specs, Owner's Manuals, Operator-Tech Manuals, PowerPoint presentations, Machine Task Instructions, RIT BOMs, spare parts lists, and other customer-specified documentation
• Write and execute test cases to verify machine function, quality control measures, and performance
• Develop and update documentation in Kneat Gx
• Conduct and document risk assessments and failure mode and effects analysis (FMEA)
• Develop technical construction files for CE machinery

What's Needed?

• 2-year technical degree with emphasis in engineering, or equivalent combination of education, coursework, internships, and work experience in manufacturing
• Minimum of 3 years' experience writing technical documentation
• Ability to develop technical documents and read blueprints
• Experience with LEAN manufacturing and Six Sigma concepts and tools preferred
• ISO experience a plus

What's In It for Me?

• Medical insurance
• Dental insurance – employer paid
• Vision insurance – employer paid
• Short and long-term disability – employer paid
• Basic Life and AD&D – employer paid
• Voluntary life insurance
• 401(k) with company contribution
• Pension plan
• Employee Stock Ownership Program (ESOP)
• Paid time off
• Flexible Spending Account (FSA) and Health Savings Account (HSA)
• Tuition reimbursement
• Employee Assistance Program (EAP)
• Wellness reimbursement
• 8 paid holidays

Key Details

• Compensation: $80K-$90K
• Schedule: Monday – Thursday 7 AM – 4 PM, Friday 7 AM – 12 PM (averaging ~45 hours per week)
• Location: Belvidere, IL (100% onsite; occasional travel to South Elgin, IL)
• Work Model: Onsite