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Computer System Validation Manager Jobs in Huntersville, NC

Eli Lilly and Company

Systems Engineer (R2-R4)

Concord, NC · 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 ...

Mastech Digital

CAD Systems Manager

Hickory, NC · On-site

$70K - $75K/yr

What we'd like you to have: - Bachelor's degree in technology or similar preferred; equivalent work experience will be considered. - 3+ years of CAD System management. - Experience with Autodesk CAD ...

Intellectt INC

Validation Engineer

Charlotte, NC · On-site

... equipment, systems, and utilities, ensuring compliance with GMP and regulatory standards. Key ... Knowledge of QMS and risk management * Familiarity with Lean/Six Sigma principles Thanks & Regards ...

GDIT

Desktop Systems Administrator

Concord, NC

$70K - $95K/yr

... m and software maintenance for the USCENTCOM COOP. * Coordinates and manages Automated Data ... Tracks the disposition of equipment throughout its lifecycle (e.g., Computer Equipment Replacement ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Huntersville, NC

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 Jul 20, 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:
Computer System Validation Manager jobs near you
Senior Computer System Validation Lead

Senior Computer System Validation Lead

OmegaHires

Concord, NC • On-site

Contractor

Posted 2 days ago

Job description

Senior Computer System Validation Lead
**Job Title: Senior Computer System Validation Lead** **Location:** Concord, NC (Complete Onsite) **Position Overview:** We are seeking a Senior Computer System Validation Lead to join our team for an onsite opportunity in Concord, NC. This role involves leading validation strategies and executing validation activities for manufacturing systems within a regulated environment, primarily in the life sciences or pharmaceutical industry. The ideal candidate will collaborate with cross-functional teams to ensure compliance with regulatory standards and support digital manufacturing initiatives. **Key Responsibilities:** - Lead end-to-end CSV lifecycle activities for manufacturing systems, including MES and automation systems. - Act as CSV Lead/SME for manufacturing programs, providing guidance on validation strategy, execution, and compliance. - Support validation for systems such as MES, SAP EWM, Tulip, SCADA, PLC, and other GMP-regulated applications. - Author, review, and approve validation documentation, including Validation Plans, URS, FS/DS, IQ/OQ/PQ Protocols, and system summaries. - Ensure compliance with FDA, GAMP5, GxP, Data Integrity principles, and internal quality systems. ** :** - 10+ years of experience in Computer System Validation within regulated manufacturing environments (Pharma/Biotech/Medical Devices). - Strong hands-on experience with MES validation and automation-integrated systems. - Proven experience working in shop-floor environments and automation systems. - Expertise in GAMP5 risk-based validation, FDA 21 CFR Part 11 & Annex 11 compliance, and Data Integrity (ALCOA+). - Ability to lead cross-functional teams, handle regulatory inspections, and manage stakeholders across IT, Quality, and Manufacturing.

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