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Senior Computer System Validation Csv Jobs (NOW HIRING)

Intellectt INC

Senior Validation Engineer

Portland, OR · On-site

Seeking a Senior Validation Engineer with strong GMP experience to support QC equipment validation and Computer System Validation (CSV) activities. Key Responsibilities: * Author & execute URS, IQ/OQ ...

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How much do senior computer system validation csv jobs pay per hour?

As of May 29, 2026, the average hourly pay for senior computer system validation csv in the United States is $64.77, according to ZipRecruiter salary data. Most workers in this role earn between $51.68 and $73.56 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Senior Computer System Validation (CSV) professional, and why are they important?

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 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 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.

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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $134,726 per year, or $64.8 per hour.
Sr. Engineer, Computer System Validation

Sr. Engineer, Computer System Validation

Axogen

Vandalia, OH

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 days ago

Job description

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

  • Friendly, open, and fun team culture that values unique perspectives
  • Company-wide dedication to profoundly impacting patients' lives
  • Comprehensive, high-quality benefits package effective on date of hire
  • Educational assistance available for all employees
  • Matching 401(k) retirement plan
  • Paid holidays, including floating holidays, to be used at your discretion
  • Employee Stock Purchase Plan
  • Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

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

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range
$92,293—$115,367 USD

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.