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Validation Engineer Biomedical Jobs in Ohio (NOW HIRING)

SIERTEK

Biomedical Equipment Technician*

Dayton, OH · On-site

Associate's degree in Biomedical Equipment Technology, Biomedical Engineering Technology ... Valid U.S. driver's license. * Ability to lift up to 51 pounds frequently and heavier equipment ...

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Validation Engineer Biomedical information

What does a validation engineer do in biomedical?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What are some typical challenges faced by validation engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are popular job titles related to Validation Engineer Biomedical jobs in Ohio?

For Validation Engineer Biomedical jobs in Ohio, the most frequently searched job titles are:

What job categories do people searching Validation Engineer Biomedical jobs in Ohio look for?

The top searched job categories for Validation Engineer Biomedical jobs in Ohio are:

Validation Engineer Biomedical jobs near you

Field Validation Engineer

Cleveland, OH • On-site

RXinsider LTD.
Marketing • 11 - 50 employees
Learn more about RXinsider LTD.external

Other

Posted 23 days ago

Key responsibilities

  • Perform validation activities including IQ, OQ, and PQ for systems and customer equipment

  • Develop, execute, and complete validation documentation such as protocols and reports

  • Troubleshoot and resolve validation-related and system performance issues in the field

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
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