Senior Validation Engineer - Medical Devices QA & Compliance

Katalyst-Healthcares-; Plymouth (MN); On-site; USD 85,000 - 115,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Validation Engineer to drive validation activities in a regulated medical device environment, focusing on IQ/OQ/PQ protocols, V&V, and CAPA-driven improvements.

The role emphasizes collaboration with Quality, Engineering, Manufacturing, and R&D teams, ensuring compliance with FDA and ISO standards while advancing process and product development.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 3–5 years of validation experience in a regulated industry (medical devices/pharma/biotech).
• Hands-on experience with IQ/OQ/PQ and process/equipment validation.

Responsibilities

• Develop, review, and execute IQ/OQ/PQ validation protocols and reports for manufacturing processes, equipment, and software.
• Support process validation, equipment qualification, and 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 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.

Skills

IQ/OQ/PQ validation

Statistical analysis

CAPA

Root cause analysis

FDA/ISO compliance

Documentation

Cross-functional collaboration

Process improvement

Education

Bachelor's degree in Engineering

Mechanical Engineering

Electrical Engineering

Biomedical Engineering

Life Sciences

Tools

Minitab

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.

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.