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Validation Engineer
Accepting applicationsSterling Engineering · Belvidere, IL
Full-Time Associate aiateganrfsoc
Posted
3d ago
Category
Test
Experience
Associate
Country
United States
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.
Show more Show less
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.
Show more Show less