Validation Engineer

Katalyst-Healthcares-; Plymouth (MN); Presencial; USD 85.000 - 115.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

IQ/OQ/PQ validation

Statistical analysis

CAPA

Root cause analysis

FDA/ISO compliance

Documentation

Cross-functional collaboration

Process improvement

Educación

Bachelor's degree in Engineering

Mechanical Engineering

Electrical Engineering

Biomedical Engineering

Life Sciences

Herramientas

Minitab

Descripción del empleo

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.