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Medical Device Computer System Validation Jobs (NOW HIRING)

ClifyX

Computer system Validation Tester

Somerset, NJ · On-site

ClifyX is seeking a Computer System Validation Tester to ensure compliance with industry standards in computerized systems validation. The role involves performing risk assessments, drafting ...

Soltech PR

WI · On-site

$80 - $100/hr

The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle ... medical device, or other FDA-regulated environment. * Strong knowledge of the computerized system ...

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Medical Device Computer System Validation information

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$10

$54

$86

How much do medical device computer system validation jobs pay per hour?

As of Sep 8, 2026, the average hourly pay for medical device computer system validation in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

What is medical device computer system validation?

Medical Device Computer System Validation (CSV) is the process of ensuring that software and computer systems used in the manufacturing, testing, or management of medical devices meet regulatory requirements and function as intended. This involves documenting that all systems are installed correctly, operate reliably, and consistently produce accurate data. CSV is critical for patient safety, product quality, and regulatory compliance, particularly with standards like FDA 21 CFR Part 11 and ISO 13485. The validation process typically includes planning, risk assessment, testing, and ongoing monitoring throughout the system's lifecycle.

What are the key skills and qualifications needed to thrive as a medical device computer system validation specialist?

To thrive as a Medical Device Computer System Validation specialist, you need a solid understanding of regulatory compliance (such as FDA 21 CFR Part 11), risk management, and computer science or engineering principles, often supported by a relevant degree or certification. Familiarity with validation protocols, quality management systems (QMS), and software tools like ALM or TrackWise is essential. Strong attention to detail, analytical thinking, and effective communication skills help ensure validation activities meet strict industry standards. These skills are vital for safeguarding patient safety, ensuring product quality, and maintaining regulatory compliance in the medical device industry.

What are some common challenges faced by professionals in medical device computer system validation and how can they be addressed?

Professionals in Medical Device Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring thorough documentation, and coordinating with cross-functional teams like IT, quality assurance, and engineering. Staying updated with current FDA guidelines and international standards (such as ISO 13485) is crucial. Clear communication and collaboration with team members can streamline validation activities and help address gaps early. Utilizing robust project management tools and maintaining organized, audit-ready documentation can also significantly reduce stress and improve efficiency.

What is the difference between Medical Device Computer System Validation vs Quality Assurance Specialist?

AspectMedical Device Computer System ValidationQuality Assurance Specialist
Primary FocusEnsuring computer systems meet regulatory and functional requirements for medical devicesMaintaining product quality through process audits and compliance
CertificationsGxP, 21 CFR Part 11, Validation certificationsISO 9001, Six Sigma, QA certifications
Work EnvironmentRegulated labs, validation teams, manufacturing settingsQuality departments, manufacturing plants, audits
Industry UsageMedical device manufacturing, regulatory submissionsProduct quality, process improvement, compliance

Medical Device Computer System Validation specialists focus on verifying that computer systems used in medical device manufacturing comply with regulatory standards. Quality Assurance Specialists oversee overall product quality and process compliance. While both roles ensure regulatory adherence, validation is specifically about system verification, whereas QA covers broader quality management.

Computer System Validation (CSV) Specialist

Wilson, NC

Pinnaql
Pharmaceutical and Medicine Manufacturing • 11 - 50 employees
Learn more about Pinnaqlexternal

Full-time

Posted 8 days ago

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Computer System Validation Specialist

Position Summary

We are seeking a Computer System Validation (CSV) Specialist/Engineer to support validation activities for computerized systems in a regulated manufacturing environment. The ideal candidate will have 34 years of hands-on CSV experience and a solid understanding of GxP requirements, system lifecycle documentation, and data integrity principles.

Key Responsibilities

  • Support the validation and lifecycle management of GxP computerized systems.
  • Develop, review, and execute validation documentation, including:
    • User Requirements Specifications (URS)
    • Functional/Design Specifications
    • Risk Assessments
    • Validation Plans
    • IQ/OQ/PQ protocols
    • Test Scripts
    • Traceability Matrices
    • Validation Summary Reports
  • Execute and document system testing and ensure appropriate resolution of discrepancies and deviations.
  • Support system implementation, upgrades, enhancements, and periodic reviews.
  • Perform computerized system risk assessments in accordance with applicable regulatory requirements and company procedures.
  • Ensure compliance with 21 CFR Part 11, GxP, data integrity, and electronic records/electronic signature requirements.
  • Collaborate with IT, Engineering, Quality, Manufacturing, Automation, and system owners throughout the system lifecycle.
  • Support change controls, deviations, CAPAs, and system retirement activities as applicable.
  • Assist with audit and inspection readiness activities related to computerized systems.
  • Maintain accurate and complete validation documentation in accordance with approved procedures.

Qualifications

  • Bachelors degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related technical discipline.
  • 34 years of experience in Computer System Validation (CSV) within a regulated environment, preferably pharmaceutical, biotechnology, medical device, or life sciences manufacturing.
  • Working knowledge of GAMP 5, 21 CFR Part 11, GxP, and data integrity principles.
  • Experience developing and executing computerized system validation documentation and testing.
  • Strong documentation, analytical, and problem-solving skills.
  • Ability to work cross-functionally with technical and quality teams.
  • Strong written and verbal communication skills.

Preferred Qualifications

  • Experience with Power BI for dashboards, reporting, data visualization, or analytics.
  • Experience validating manufacturing, laboratory, quality, or enterprise systems.
  • Experience supporting system upgrades, implementation projects, or digital transformation initiatives.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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