Field Validation Engineer

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

CLEVELAND, OHIO

Job Summary:

The Field Validation Engineer at Rees Scientific is responsible for executing validation and qualification activities for environmental monitoring systems and customer equipment in regulated environments. This role supports installation, validation, calibration, and system verification while ensuring all activities meet established operational, quality, and regulatory standards.

The Field Validation Engineer serves as a technical resource in the field, supporting validation lifecycle activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This position does not include people-management responsibilities and is focused on technical execution, compliance, and customer satisfaction.

Working closely with Field Service leadership, Technical Support, Engineering, Quality, and Project teams, the Field Validation Engineer plays a critical role in ensuring accurate, compliant, and efficient validation delivery across assigned regions.

Key Responsibilities:

Field Validation Execution & Technical Support

• 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

Quality, Documentation & Compliance

• 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

Customer Support & Collaboration

• 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

Continuous Improvement & Training

• 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

Qualifications & Experience

• Bachelor’s degree from a four-year college or university in Engineering (Electrical, Mechanical, Biomedical, Chemical, or related discipline) preferred; or
• Five to seven years of validation experience in pharmaceutical, biotechnology, or regulated manufacturing environments; or
• Equivalent combination of education and experience
• Strong technical background in validation lifecycle (IQ/OQ/PQ), CSV, and temperature mapping
• Experience with GMP, FDA regulations, GAMP, and data integrity requirements
• Strong technical writing skills for validation documentation (protocols, reports, SOPs)
• Ability to work independently with minimal supervision
• Strong organizational, documentation, and communication skills

Physical Requirements:

• Ability to travel extensively within assigned regions, including overnight and extended travel
• Ability to lift and carry up to 50 pounds
• Ability to stand, walk, bend, reach, kneel, and climb ladders as required
• Comfortable working in laboratories, cleanrooms, and industrial environments, including temperature variations
• Ability to follow all safety protocols and procedures while performing field validation activities