Field Validation Engineer: In-Field GMP/CSV Expert

RXinsider LTD.; Cleveland (OH); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Rees Scientific is seeking a Field Validation Engineer to execute IQ, OQ, and PQ validation for environmental monitoring systems and customer equipment in regulated facilities.

You will perform temperature mapping, calibration verification, and CSV activities, while ensuring GMP, FDA, and data integrity standards are maintained across assigned regions.

Travel up to extensive regional field work is required, with a focus on accurate documentation, regulatory compliance, and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering preferred; or equivalent.
• 5–7 years of validation experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Strong knowledge of IQ/OQ/PQ, CSV, and temperature mapping.
• Experience with GMP, FDA regulations and data integrity.
• Strong technical writing and ability to work independently.

Responsibilities

• Perform IQ, OQ, and PQ validation for Rees Scientific systems and customer equipment.
• Execute temperature mapping and calibration verification for field systems.
• Support computer system validation (CSV) activities in alignment with GAMP and data integrity standards.
• Troubleshoot and resolve validation-related and system performance issues in the field.
• Verify system configuration, functionality, and regulatory compliance.
• Review validation protocols and documentation prior to execution and provide updates.
• Develop, review, and maintain validation documentation including protocols and reports.

Skills

Validation lifecycle

GMP/FDA knowledge

Technical writing

CSV

Temperature mapping

Independent work

Education

Bachelor’s degree in Engineering

Job description

Rees Scientific is seeking a Field Validation Engineer to execute IQ, OQ, and PQ validation for environmental monitoring systems and customer equipment in regulated facilities.

You will perform temperature mapping, calibration verification, and CSV activities, while ensuring GMP, FDA, and data integrity standards are maintained across assigned regions.

Travel up to extensive regional field work is required, with a focus on accurate documentation, regulatory compliance, and customer satisfaction.