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Computer System Validation Manager Jobs in Wilson, NC

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Computer System Validation Manager information

See Wilson, NC salary details

$41.5K

$92.1K

$140.3K

How much do computer system validation manager jobs pay per year?

As of Sep 6, 2026, the average yearly pay for computer system validation manager in Wilson, NC is $92,134.00, according to ZipRecruiter salary data. Most workers in this role earn between $65,100.00 and $115,400.00 per year, depending on experience, location, and employer.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What cities near Wilson, NC are hiring for Computer System Validation Manager jobs?

Cities near Wilson, NC with the most Computer System Validation Manager job openings:

Computer System Validation (CSV) Specialist

Validation & Engineering Group, Inc.

Wilson, NC โ€ข On-site

Full-time

Posted 5 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 3๏ฟฝ4 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
  • Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related technical discipline.
  • 3๏ฟฝ4 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.