Validation Engineer

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

Job Summary

We are seeking 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 have hands-on experience developing and executing validation protocols, working with FDA and ISO requirements, conducting root cause analysis, and supporting quality and compliance initiatives.

Job Summary

We are seeking 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 have hands-on experience developing and executing validation protocols, working with FDA and ISO requirements, conducting root cause analysis, and supporting quality and compliance initiatives.

Roles And Responsibilities

• Develop, review, and execute IQ/OQ/PQ validation protocols and reports for manufacturing processes, equipment, and software.
• Support process validation, equipment qualification, and verification & validation (V&V) activities.
• Review validation documentation and identify compliance gaps or deviations.
• Support investigation and resolution of validation-related issues, including CAPA and corrective actions.
• Perform root cause analysis (RCA) and support implementation of effective corrective and preventive actions.
• Support FDA inspection readiness and ongoing quality system activities.
• Ensure validation activities comply with applicable FDA regulations and ISO standards.
• Participate in process improvement and continuous improvement initiatives.
• Apply statistical methods and data analysis to evaluate process performance and validation results.
• Use tools such as Minitab for statistical analysis, including interpretation of P-values and other statistical measures.
• Prepare and maintain validation protocols, reports, risk assessments, and supporting documentation.
• Collaborate with Quality, Engineering, Manufacturing, R&D, and other cross‑functional teams to manage validation projects.
• Work directly with customers and internal stakeholders to understand validation requirements and project expectations.
• Support new product development activities and ensure appropriate validation requirements are incorporated.
• Maintain accurate and compliant validation records in accordance with company procedures and regulatory requirements.

Education & Experience:

• Bachelor's degree in engineering, Science, or a related technical discipline.
• Degrees in areas such as Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Industrial Engineering, Manufacturing Engineering, or Life Sciences are preferred.
• 3-5 years of validation experience in a regulated industry, preferably medical devices, pharmaceuticals, biotechnology, or other highly regulated manufacturing environments.
• Hands-on experience with IQ/OQ/PQ and process/equipment validation.