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Computer System Validation Manager Jobs in Huntersville, NC

... computer systems. โ€ข Performs routine testing for product release and stability studies. โ€ข Helps develop lab documents to support compliance with GMP. โ€ข Performs routine procedures to monitor ...

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 ...

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 ...

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 ...

Systems Engineer (R2-R4)

Concord, NC ยท On-site

$89K - $102K/yr

... management and user adoption strategies for large-scale system implementations; 1 year of experience with computer system validation, including generation of testing artifacts for MES; 1 year of ...

Systems Engineer (R2-R4)

Concord, NC ยท On-site

$89K - $102K/yr

... management and user adoption strategies for large-scale system implementations; 1 year of experience with computer system validation, including generation of testing artifacts for MES; 1 year of ...

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Computer System Validation Manager information

See Huntersville, NC salary details

$44.6K

$99.1K

$150.8K

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

As of Aug 9, 2026, the average yearly pay for computer system validation manager in Huntersville, NC is $99,070.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,000.00 and $124,100.00 per year, depending on experience, location, and employer.

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 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 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 the most commonly searched types of Computer System Validation jobs in Huntersville, NC? The most popular types of Computer System Validation jobs in Huntersville, NC are:
What job categories do people searching Computer System Validation Manager jobs in Huntersville, NC look for? The top searched job categories for Computer System Validation Manager jobs in Huntersville, NC are:
What cities near Huntersville, NC are hiring for Computer System Validation Manager jobs? Cities near Huntersville, NC with the most Computer System Validation Manager job openings:

Validation Manager - Pharma

skyeblue consulting

Hickory, NC โ€ข On-site

Full-time

Re-posted 9 days ago


Job description

Company Description

Skye Blue Consulting has been engaged to find a Validation Manager for one of our top clients in Western North Carolina. The client is a small (but growing!) pharma firm with competitive salaries, great benefits and is located in the beautiful foothills area.

Job Description

Job Task(s)
Manages all aspects of the Validation/Calibration department.
Designs and implements systems to assure quality of data processing across multiple study sites.
Works with database designers to set up computer systems.
Performs routine testing for product release and stability studies.
Helps develop lab documents to support compliance with GMP.
Performs routine procedures to monitor adherence to guidelines.

Computer Skill(s)
Should have knowledge of Database software; Statistical software; Project Management software; Spreadsheet software and Word Processing software.
Knowledge of US Pharmacopeia/National Formulary analytic methods: Knowledge of SPC and DOE is desired but not required.

Qualifications

Education Requirements
This position requires the following minimum education:
Bachelor's degree (B.A.) from a four year college OR equivalent combination of education and experience. An advanced degree is preferred.
Work Experience Requirements
3-5 years related experience and/or training

Physical Demand(s)
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk and use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision and ability to adjust focus.

Additional Information

All your information will be kept confidential according to EEO guidelines.