Senior Validation Engineer - Medical Devices QA & Compliance

Creative Solutions Services, LLC; 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

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.