Senior Validation Engineer – Medical Devices & Compliance

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

Job summary

Katalyst CRO in Minnesota seeks an experienced Validation Engineer to support validation activities, quality systems, process improvements, and new product development within a regulated medical device environment.

The ideal candidate will develop and execute IQ/OQ/PQ validation protocols, work with FDA and ISO requirements, perform root cause analysis, support CAPA and regulatory readiness, and collaborate across Quality, Engineering, Manufacturing, and R&D to ensure compliant validation

Qualifications

• Bachelor's degree in engineering, science, or a related technical discipline.
• 3–5 years of validation experience in a regulated industry (medical devices/pharma).
• Hands-on IQ/OQ/PQ validation experience with documentation.
• Familiarity with FDA and ISO requirements and quality systems.

Responsibilities

• Develop, review, and execute IQ/OQ/PQ validation protocols and reports.
• Support process validation, equipment qualification, and V&V activities.
• Review validation docs and identify compliance gaps or deviations.
• Lead RCA and support CAPA and corrective actions.
• Participate in FDA inspection readiness and quality system activities.
• Apply statistics to evaluate process performance and results.
• Collaborate with Quality, Engineering, Manufacturing, and R&D teams.

Skills

IQ/OQ/PQ validation

Root cause analysis

CAPA

Statistical analysis

Minitab

FDA regulations

Education

Bachelor's degree in engineering or related field

Engineering disciplines (Mechanical, Electrical, Biomedical, etc.)

Tools

N/A

Job description

Katalyst CRO in Minnesota seeks an experienced Validation Engineer to support validation activities, quality systems, process improvements, and new product development within a regulated medical device environment.

The ideal candidate will develop and execute IQ/OQ/PQ validation protocols, work with FDA and ISO requirements, perform root cause analysis, support CAPA and regulatory readiness, and collaborate across Quality, Engineering, Manufacturing, and R&D to ensure compliant validation