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Senior Computer System Validation Csv Jobs in Ohio

RXinsider LTD.

Field Validation Engineer

Cleveland, OH · On-site

$90 - $130/hr

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

Resilience

CSV Engineer III

West Chester, OH · On-site

$85 - $133.75/hr

Hands-on experience with automation and computer system validation (CSV). * Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, ...

ATS Automation

Automation Engineer

Lewis Center, OH · On-site

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Ensure commissioning and qualification activities align with ...

ATS Automation

Senior Automation Engineer

Lewis Center, OH · On-site

$98K - $129K/yr

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...

Deloitte

System Test and Validation Lead

Cleveland, OH · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Dayton, OH · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Cleveland, OH · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Dayton, OH · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

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Senior Computer System Validation Csv information

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the most commonly searched types of Computer System Validation Csv jobs in Ohio?

The most popular types of Computer System Validation Csv jobs in Ohio are:

What are popular job titles related to Senior Computer System Validation Csv jobs in Ohio?

For Senior Computer System Validation Csv jobs in Ohio, the most frequently searched job titles are:

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Senior Computer System Validation Csv jobs near you

Field Validation Engineer

Rees Scientific Corporati

Cleveland, OH • On-site

Full-time

Re-posted 16 days ago

Key responsibilities

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

  • Develop, execute, and complete validation documentation including protocols, reports, and supporting records

  • 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