Field Validation Engineer - IQ/OQ/PQ & CSV Expert

RXinsider LTD.; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Rees Scientific is seeking a Field Validation Engineer to execute IQ/OQ/PQ validation for environmental monitoring systems and customer equipment in regulated environments. The role focuses on technical execution, compliance, and customer satisfaction, with extensive field work and cross-functional collaboration with Field Service leadership, Engineering, Quality, and Project teams.

Responsibilities include validation documentation, CSV activities per GAMP and data integrity standards, and

Qualifications

• Bachelor’s degree in Engineering (Electrical, Mechanical, Biomedical, Chemical, or related) preferred.
• 5–7 years of validation experience in pharmaceutical, biotechnology, or regulated environments.
• Strong knowledge of IQ/OQ/PQ, CSV, and temperature mapping.
• Experience with GMP, FDA regulations, GAMP, and data integrity requirements.
• Excellent technical writing and documentation skills.
• Ability to work independently with minimal supervision.
• Strong organizational and communication skills.

Responsibilities

• Perform validation activities including IQ, OQ, and PQ for Rees Scientific systems and customer equipment.
• Execute temperature mapping, calibration verification, and environmental monitoring system validation.
• 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 compliance with technical specifications and regulatory requirements.
• Review validation protocols and job documentation prior to execution and provide required updates.
• Develop, execute, and complete validation documentation including protocols, reports, and supporting records.
• Ensure all validation activities comply with GMP, GLP, FDA, ISO, and customer-specific requirements.
• Support investigations, deviations, CAPAs, and change control activities as required.
• Maintain audit-ready documentation and validation records in accordance with company and regulatory standards.
• Communicate effectively with customers regarding validation activities, system performance, and compliance requirements.
• Support customer escalations and validation-related technical inquiries.
• Collaborate with internal teams including Engineering, Technical Support, Quality, and Program Management.
• Provide guidance to field service personnel on validation-related activities when needed.
• Maintain current knowledge of validation practices, regulatory requirements, and Rees Scientific systems.
• Participate in required training and certification programs.
• Provide feedback to Field Service leadership regarding validation processes, tools, and service improvements.

Skills

IQ/OQ/PQ

CSV

Temperature mapping

GAMP

Data integrity

Technical writing

Customer communication

Independent work

Regulatory compliance

Education

Bachelor’s degree in Engineering

Equivalent combination of education and experience

Job description

Rees Scientific is seeking a Field Validation Engineer to execute IQ/OQ/PQ validation for environmental monitoring systems and customer equipment in regulated environments. The role focuses on technical execution, compliance, and customer satisfaction, with extensive field work and cross-functional collaboration with Field Service leadership, Engineering, Quality, and Project teams.

Responsibilities include validation documentation, CSV activities per GAMP and data integrity standards, and