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How much do computer system validation jobs pay per hour?

As of May 28, 2026, the average hourly pay for computer system validation in Ohio is $51.64, according to ZipRecruiter salary data. Most workers in this role earn between $39.76 and $61.25 per hour, depending on experience, location, and employer.

What is a Computer System Validation job?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

What are some typical challenges faced in Computer System Validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
More about Computer System Validation jobs
What are the most commonly searched types of Computer System Validation jobs in Ohio? The most popular types of Computer System Validation jobs in Ohio are:
What are popular job titles related to Computer System Validation jobs in Ohio? For Computer System Validation jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching Computer System Validation jobs in Ohio look for? The top searched job categories for Computer System Validation jobs in Ohio are:
Computer System Validation jobs near you
Sr. Engineer, Computer System Validation

Sr. Engineer, Computer System Validation

Axogen

Vandalia, OH

Other

Posted 9 days ago

Job description

Job Summary of the Sr. Engineer, Computer System Validation

The Sr. Engineer, Computer System Validation, will demonstrate strong expertise in Computer System Validation (CSV), data integrity, and periodic review of systems. This role will support validation and compliance efforts for computerized systems with GxP impact and coordinate between business units and IT, as needed.  This position reports to the Supervisor, Quality Systems and will partner closely with IT, QA, and various business units (e.g., R&D, Clinical, Operations, and Finance). Occasional travel to other Axogen sites may be required.

Requirements of the Sr. Engineer, Computer System Validation

  • Bachelor's Degree in Biomedical Engineering, Information Technology, Pharmaceutical Sciences, or related field, along with 5 years of experience in the Software Industry, specializing in GxP and validated systems.
  • In-depth knowledge of GAMP 5 and 21 CFR Part 11 principles.
  • Strong track record in authoring, executing, and approving validation documentation across the full software development lifecycle (SDLC).
  • Strong understanding of QMS systems and document routing/tracking in a compliance-driven environment.
  • Experience managing change controls and periodic review processes.
  • Strong verbal and written communication skills - able to engage technical and non-technical audiences.
  • Familiarity with ERP, LIMS, MES, ELN, and SaaS-based GxP systems.
  • Formal training or certification in Computer System Validation (CSV), such as courses offered by ISPE, NSF, CfPIE, or equivalent recognized organizations preferred.
  • Knowledge of MasterControl or other E-QMS platforms.

Responsibilities of the Sr. Engineer, Computer System Validation

The specific duties of the Sr. Engineer, Computer System Validation include but are not limited to:

  • Develop, execute and review risk-based validation strategies aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity standards.
  • Co-author, review, and/or approve validation deliverables: URS, FRS, Risk Assessments, IQ/OQ/PQ Protocols, Summary Reports, Traceability Matrices, and Data Integrity Checklists.
  • Support validation efforts for new and upgraded GxP systems, including but not limited to SaaS, ERP, EBR, LIMS, MES, and QMS platforms.
  • Manage periodic review of computerized systems by collaborating with Business and System owners to execute the reviews, identify any gaps and plan corrective actions.
  • Maintain and improve the CSV program in alignment with regulatory guidance and regulations.
  • Support internal and external audits related to computerized systems and data integrity compliance.
  • Elicit, document, and manage business and user requirements through workshops, interviews, and process mapping.
  • Translate requirements into functional specifications, traceability matrices, and change controls.
  • Serve as a trusted liaison between business stakeholders, QA, technical teams, and external vendors to drive project milestones while ensuring seamless communication and compliance.
  • Route and track validation documents and project deliverables in the QMS for review and approval.
  • Create, manage and/or review change controls in the QMS for system updates or improvements and proactively drive them forward through the full approval lifecycle.
  • Ensure that document updates, system revisions, and process changes are appropriately documented and maintained according to regulatory expectations.
  • Ensure vendor deliverables meet Axogen's internal quality and regulatory standards.
  • Identify process gaps, propose improvements, and advocate for continuous enhancement of validation and compliance practices.

Location (any of these)

APC  - 913 Industrial Drive Place, Vandalia, OH 45377

Tampa HQ - 111 West Oak Avenue, Tampa, FL  33602

Alachua HQ - 13631 Progress Boulevard #400, Alachua, FL 32615

Benefits/Compensation

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