Validation Engineer

VALIDATION ENGINEER

Belvidere, IL | Direct Hire | Full-Time | Onsite

⚠ WORK AUTHORIZATION REQUIREMENT

Applicants must be authorized to work in the United States without current or future sponsorship.

This employer DOES NOT provide:

H-1B Sponsorship

H-1B Transfers

OPT/CPT Sponsorship

TN Sponsorship

Employment-Based Visa Sponsorship of Any Kind

Candidates requiring sponsorship now or in the future will not be considered.

ABOUT THE OPPORTUNITY

Join a growing employee-owned automation company that designs and builds custom high-speed assembly equipment for the:

• Medical Device Industry
• Consumer Products Industry
• Industrial Manufacturing Industry

We are seeking a Validation Engineer to support equipment qualification, commissioning, and validation activities for custom automation systems.

RESPONSIBILITIES

Validation & Qualification

• Develop and execute:
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Testing & Commissioning

• Support Factory Acceptance Testing (FAT)
• Support Site Acceptance Testing (SAT)
• Assist with equipment commissioning activities

Documentation

• Create and maintain:
• Validation Protocols
• Qualification Reports
• Commissioning Documentation
• Technical Documentation

Engineering Collaboration

Partner with Engineering teams to develop and review:

• Functional Design Specifications
• Software Design Specifications
• Hardware Design Specifications
• Vision System Specifications
• Operator Manuals

Compliance & Risk Management

• Perform Risk Assessments
• Participate in FMEA Activities
• Support cGMP Compliance Reviews
• Maintain validation records within Kneat Gx

QUALIFICATIONS

Required

Associate Degree in Engineering Technology, Manufacturing Technology, or related field

3+ years of validation experience in a regulated manufacturing environment

Experience with:

• DQ, IQ, OQ, and PQ Protocols
• FAT and SAT Activities
• Engineering Drawings and Technical Documentation
• cGMP Requirements

APPLY TODAY

If you have experience validating equipment in a regulated manufacturing environment and are looking to join a stable, employee-owned organization, we encourage you to apply.