Validation Engineer

Katalyst CRO; Minneapolis (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO in Minneapolis is looking for an experienced Test/Validation Engineer. You will work with manufacturing validation, ensuring compliance through IQ, OQ, and PQ for test equipment.

The ideal candidate should have a Bachelor's degree in Engineering and over 5 years of relevant experience, particularly with LabVIEW and NI Test Stand. This role supports critical projects in regulated environments like Medical Devices and Pharmaceuticals.

Qualifications

• 5+ years of experience in Test Engineering, Manufacturing Validation, or V&V within regulated industries.
• Hands-on experience qualifying automated manufacturing test equipment.
• Strong knowledge of IQ, OQ, and PQ validation methodologies.
• Experience in regulated environments such as Medical Devices, Life Sciences, Pharmaceutical, or FDA/GMP.

Responsibilities

• Perform IQ, OQ, and PQ for manufacturing test equipment.
• Execute V&V activities to ensure compliance with requirements.
• Develop and review validation protocols, test plans, and reports.
• Collaborate with teams to resolve technical issues.

Skills

Manufacturing validation

Automated test equipment qualification

Verification & Validation (V&V)

LabVIEW

NI Test Stand

Functional testing

Documentation preparation

Analytical skills

Troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

LabVIEW

NI Test Stand

Job description

Job Summary

We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within regulated industries.

The ideal candidate will have hands‑on experience in LabVIEW, NI Test Stand, IQ/OQ/PQ validation, functional testing, and preparation of validation documentation to support manufacturing equipment qualification and compliance.

Responsibilities

• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing test equipment.
• Execute Verification & Validation (V&V) activities to ensure manufacturing systems and equipment meet predefined requirements.
• Qualify and validate automated manufacturing test equipment used in production environments.
• Develop, execute, and review validation protocols, test plans, traceability matrices, and validation reports.
• Conduct functional testing to verify equipment performance and product quality.
• Utilize LabVIEW and NI Test Stand for automated test development, execution, and validation.
• Support manufacturing equipment qualification activities in accordance with quality and regulatory requirements.
• Collaborate with Manufacturing, Quality, Engineering, and Validation teams to resolve technical issues and ensure compliance.
• Maintain complete and accurate validation documentation in accordance with company procedures and regulatory standards.
• Participate in continuous improvement initiatives to enhance validation processes and manufacturing efficiency.

Requirements

• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Manufacturing, or related field).
• 5+ years of experience in Test Engineering, Manufacturing Validation, or Verification & Validation (V&V) within regulated industries.
• Hands‑on experience qualifying automated manufacturing test equipment.
• Strong knowledge and practical experience with IQ, OQ, and PQ validation methodologies.
• Experience performing Functional Testing and Verification & Validation (V&V) activities.
• Proficiency with LabVIEW and NI Test Stand.
• Experience preparing validation protocols, traceability matrices, validation reports, and supporting documentation.
• Familiarity with manufacturing equipment qualification processes.
• Strong analytical, troubleshooting, and problem‑solving skills.
• Excellent documentation, communication, and cross‑functional collaboration skills.
• Experience working in regulated environments such as Medical Devices, Life Sciences, Pharmaceutical, or FDA/GMP‑regulated manufacturing is preferred.