Validation Engineer

Katalyst CRO; Minneapolis (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Minneapolis, MN is seeking an experienced Test/Validation Engineer to lead IQ/OQ/PQ activities and V&V for manufacturing test equipment used in regulated environments. You will apply LabVIEW and NI TestStand for automated test development, prepare validation documentation, and collaborate with Manufacturing, Quality, Engineering, and Validation teams to ensure compliant performance.

This role focuses on continuous improvement of validation processes and maintaining complete,

Qualifications

• Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Manufacturing, or related field).
• 5+ years of experience in Test Engineering, Manufacturing Validation, or V&V in regulated industries.
• Experience qualifying automated manufacturing test equipment.
• Strong IQ, OQ, and PQ validation knowledge and hands-on experience.
• Proficient with LabVIEW and NI TestStand.
• Experience preparing validation protocols, traceability matrices, reports, and supporting documentation.
• Familiarity with manufacturing equipment qualification processes.
• Excellent documentation and cross-functional collaboration skills.
• Experience in regulated environments such as Medical Devices, Life Sciences, Pharmaceutical, or FDA/GMP-regulated manufacturing preferred.

Responsibilities

• Perform IQ, OQ, and PQ for manufacturing test equipment.
• Execute V&V activities to ensure manufacturing systems meet requirements.
• Qualify automated test equipment used in production.
• Develop, execute, and review validation protocols, test plans, traceability matrices, and validation reports.
• Conduct functional testing to verify equipment performance.
• Utilise LabVIEW and NI TestStand for automated test development and validation.
• Support equipment qualification activities in line with quality and regulatory requirements.
• Collaborate with Manufacturing, Quality, Engineering, and Validation teams to resolve issues and ensure compliance.
• Maintain complete validation documentation per procedures and regulatory standards.
• Participate in continuous improvement initiatives to enhance validation processes and efficiency.

Skills

V&V methodologies

Validation documentation

Cross-functional collaboration

Analytical problem-solving

Regulated manufacturing environments

Documentation and communication

Education

Bachelor's degree in Engineering

Tools

LabVIEW

NI TestStand

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.

Roles & 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.
• Utilise 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 / Qualifications

• 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.