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Computer System Validation Manager Jobs in North Carolina

Deloitte

System Test and Validation Lead

Raleigh, NC · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Charlotte, NC · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Raleigh, NC · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Charlotte, NC · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Charlotte, NC · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

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Computer System Validation Manager information

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 are popular job titles related to Computer System Validation Manager jobs in North Carolina?

For Computer System Validation Manager jobs in North Carolina, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Manager jobs in North Carolina look for?

The top searched job categories for Computer System Validation Manager jobs in North Carolina are:

What cities in North Carolina are hiring for Computer System Validation Manager jobs?

Cities in North Carolina with the most Computer System Validation Manager job openings:

Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in North Carolina as of August 2026, with employment types broken down into 80% Full Time, 5% Part Time, and 15% Contract. Highlights an 86% In-person, 5% Hybrid, and 9% Remote job distribution.

Computer System Validation Specialist

Quality Chemical Laboratories

Wilmington, NC

Full-time

Re-posted 20 days ago

Job description

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Computer System Validation Specialist.

Responsibilities:

  • Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle. Documentation includes Computer System Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
  • Track and resolve deviations/exceptions during qualification activities.
  • Work with company management to implement changes and upgrades to computer systems
  • Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications
  • Communicate Computer System Validation approaches and requirements during audits.
  • Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes

Qualifications:

  • Two (2) years of experience with Computer System Validation in GxP environment (preferably pharmaceutical industry).
  • Experience in writing computer system test scripts, validation protocols and summary reports
    Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation to complete tasks
  • Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution
  • Capable of managing multiple sub-projects, duties and tasks
  • Effective at communicating clearly and concisely, both orally and in writing
  • Able to work both independently and as a member of a cross-functional project team

Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers.   

QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility. 

QCL is an equal opportunity employer.


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