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Computer System Validation Remote Jobs in Cary, NC

CREO

Senior Analyst - GxP IT QA/CSV

Durham, NC · On-site +1

This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA) per FDA guidance and GAMP 5. * Lead technical discussions, document ...

CREO

Senior Analyst - GxP IT QA/CSV

Durham, NC · Remote

This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA) per FDA guidance and GAMP 5. * Lead technical discussions, document ...

Valspec

QA Consultant

Holly Springs, NC · Remote

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... Remote Employment Type: Contract / Consulting (6-12+ months) Start Date: ASAP About the Role: We ...

Koerber

Senior Application Architect

Apex, NC · On-site +1

... computer system validation documentation for pharmaceutical companies * Strong knowledge of MES, ERP, and Level 2 system architecture, with a broad understanding of related business functions

QVC

QVC Customer Service Specialist

Raleigh, NC · Remote

$15/hr

Follow QVC computer system requirements. * Troubleshoot own technical problems (partner with IT when needed). * Available to work weekends, holidays, and additional hours. This is a remote position.

QVC

QVC Customer Service Specialist

Raleigh, NC · Remote

$15/hr

Follow QVC computer system requirements. * Troubleshoot own technical problems (partner with IT when needed). * Available to work weekends, holidays, and additional hours. This is a remote position.

Redolent, Inc

Software Engineer

Durham, NC · On-site +1

Durham NC or Remote Duration: 24+ Months Description: Xperi invents, develops and delivers ... Track computer system issues through to resolution Properly escalate unresolved issues to ...

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How much do computer system validation remote jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for computer system validation remote in Cary, NC is $50.32, according to ZipRecruiter salary data. Most workers in this role earn between $38.75 and $59.66 per hour, depending on experience, location, and employer.

What is computer system validation (CSV) in a remote job context?

Computer system validation (CSV) is a process used to ensure that IT systems and software used in regulated industries (such as pharmaceuticals or healthcare) work as intended and comply with relevant regulations. In a remote job context, CSV professionals perform validation tasks, documentation, and system testing from an offsite location, often collaborating with teams via digital tools. This remote work typically involves reviewing validation protocols, writing reports, and ensuring compliance with standards like FDA 21 CFR Part 11, all while leveraging secure online platforms to communicate and manage documentation.

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

To excel as a Computer System Validation Remote professional, you need a solid understanding of regulatory compliance (such as FDA 21 CFR Part 11), risk management, and validation lifecycle processes, often supported by a degree in computer science, engineering, or a related field. Familiarity with validation software, quality management systems (QMS), and documentation tools is typically required, along with certifications like GAMP or Six Sigma being advantageous. Strong attention to detail, analytical thinking, and effective remote communication are crucial soft skills for this role. These competencies ensure validated systems meet compliance standards, minimize risks, and support seamless collaboration in a regulated, distributed environment.

What is the difference between Computer System Validation Remote vs Computer System Validation on-site?

AspectComputer System Validation RemoteComputer System Validation on-site
Work EnvironmentPerforms validation tasks remotely, often from home or a different location from the client site.Works directly at the client or company site, conducting validation activities in person.
Required CredentialsTypically requires certifications like GxP, 21 CFR Part 11, and validation experience, applicable in both settings.Same certifications as remote roles, with additional familiarity with on-site equipment and facilities.
Industry UsageCommon in industries like pharmaceuticals and biotech where remote oversight is feasible.Traditional in regulated industries requiring on-site validation activities.

Both roles require similar certifications and industry knowledge, but the main difference lies in the work environment—remote versus on-site. Remote validation offers flexibility, while on-site validation involves direct interaction at the facility.

What are some common challenges faced by Computer System Validation professionals working remotely, and how can they be addressed?

Remote Computer System Validation (CSV) professionals often encounter challenges such as coordinating validation activities across distributed teams and ensuring secure access to sensitive documentation. Effective communication and use of collaborative tools are crucial for managing documentation reviews, test execution, and issue resolution. Establishing clear validation protocols and regular virtual check-ins with cross-functional teams can help maintain compliance and project momentum. Additionally, leveraging secure cloud-based validation platforms can streamline approvals and maintain data integrity while working remotely.
What are popular job titles related to Computer System Validation Remote jobs in Cary, NC? For Computer System Validation Remote jobs in Cary, NC, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Remote jobs in Cary, NC look for? The top searched job categories for Computer System Validation Remote jobs in Cary, NC are:
What cities near Cary, NC are hiring for Computer System Validation Remote jobs? Cities near Cary, NC with the most Computer System Validation Remote job openings:
Computer System Validation Remote jobs near you
Infographic showing various Computer System Validation Remote job openings in Cary, NC as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $104,669 per year, or $50.3 per hour.
Senior Analyst - GxP IT QA/CSV

Senior Analyst - GxP IT QA/CSV

CREO

Durham, NC • On-site, Remote

Full-time

Posted 8 days ago

Job description

JOB DESCRIPTION OVERVIEW
CREO Senior Analysts in IT Compliance and Quality take on a proactive, hands-on role collaborating with senior staff to help clients navigate complex regulatory requirements while enabling modern, efficient IT solutions. This role requires independent execution, ownership of key workstreams, and delivery of high-quality, client-ready Computerized System Validation (CSV) deliverables. Experience with GMP / Supply Chain Management is required and may include Batch Disposition, Inventory Management, Distribution etc.
Senior Analysts are highly motivated, self-directed professionals with strong technical, analytical, and communication skills. In this role, you will execute IT compliance-focused workstreams, distill complex regulatory and technical concepts into actionable insights, and support technology projects and operations across the life sciences industry.
This role will serve clients nationally and preferably be based in one of the US life science hubs (ideally the Research Triangle Park NC or Boston MA and alternatively San Diego or San Francisco CA)
POSITION RESPONSIBILITIES
  1. Lead and manage IT compliance and quality projects
  • Deliver client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health authority regulations, privacy regulations (GDPR, CCPA, etc.) or CAP/CLIA regulations.
  • Oversee the end-to-end lifecycle of IT compliance projects, from initial assessment and requirements gathering to implementation, validation, and post-implementation support. This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA) per FDA guidance and GAMP 5.
  • Lead technical discussions, document key compliance decisions, and track action items.
  • Ensure that projects meet client expectations, are completed on time, and align with relevant regulations and industry best practices (including 21 CFR Part 11, EU Annex 11), emphasizing true risk-based approaches to validation.
  • Maintain personal billable utilization at the rate of 1700 hours per year.
  1. Develop compliance-focused client deliverables.
  • Create high-quality, client-ready deliverables that communicate complex IT compliance requirements and solutions in a clear and compelling way.
  • Utilize advanced skills in Excel and PowerPoint to develop detailed compliance roadmaps, IT strategy documents, system validation plans, and risk assessments.
  • Design technology presentations and reports that articulate business value and demonstrate how the proposed solutions will address client compliance challenges, improve data integrity, and mitigate risks.
  • Develop Policies, Procedures, Forms, and Templates to drive regulatory compliance in the IT domain.
  • Develop formal systems validation documentation (eg Validation Plans, Requirements/Specifications, Risk Assessments, Test Plans, Trace Matrices etc.)
  1. Assist clients to improve and modernize their approaches to IT compliance
  • Lead data collection, IT analysis, and assessments related to IT compliance and Data Integrity.
  • Take the lead in gathering data and conducting analyses to understand and remediate client compliance challenges.
  • Conduct system audits, evaluate IT systems for compliance gaps, assess data integrity risks, and identify opportunities for compliance improvement and automation.
  • Assist customers to evaluate and/or implement technologies that automate compliance tasks, including ALM/VLM solutions or automated testing software, as well as ITSM solutions to manage change control.
  • Design technology solutions and architectures that meet regulatory requirements and incorporate best practices for data governance and security.
  • Develop sophisticated models for assessing IT compliance, cost structures, and risk mitigation.
  • Experience with qualification and/or validation of on-premises and cloud-based infrastructure and applications, including SaaS.
  • Manage and communicate complex IT compliance concepts to both technical and non-technical audiences; this will be critical to driving project success and ensuring that client expectations are consistently met or exceeded.
  1. Contribute to business development.
    • Actively contribute to business development activities by identifying IT compliance opportunities within existing client relationships and helping to acquire new clients.
    • Conduct compliance assessments, prepare proposals for IT compliance solutions, and contribute to the firm's position as a leader in IT compliance within the life sciences industry.
    • Foster relationships with senior IT and Quality executives and influence decision-makers; this will be crucial to driving revenue growth and expanding the firm's IT compliance consulting offerings.

REQUIRED QUALIFICATIONS, SKILLS, AND EXPERIENCE
  • 3 to 5+ years of consulting experience or equivalent work experience in IT compliance within the life sciences industry.
  • Experience in 2 or more regulated life science domains eg GCP, GMP, GLP, GDP, PV etc.
  • Experience with IT compliance or CSV in at least 2 to 3 life science functions (eg. Medical Device software, Clinical, Quality, Supply Chain/Manufacturing, Pharmacovigilance, Labs etc.
  • Experience with several leading software brands used extensively in life sciences (such as SAS, Veeva, TrackWise, MasterControl, Medidata, ZenQMS, Labvantage, Labware, Sapio, Benchling, Blue Mountain, BatchMaster, SAP, NetSuite, MS Dynamics etc.)
  • Experience with qualification of infrastructure for GxP use is an advantage.
  • Experience with Lab systems is an advantage.
  • Bachelor's degree in a relevant field (e.g., Computer Science, Information Systems, or a Life Sciences discipline).
  • Leadership skills with experience managing IT or Quality teams and mentoring junior staff in a compliance-focused environment.
  • Proven ability to design and implement solutions that drive compliance, mitigate risk, and provide business value.
  • Deep understanding of regulations and standards relevant to the life sciences industry at the intersections of Technology, Quality, Privacy and Compliance including but not limited to:
    • 21 CFR Part 11
    • EU Annex 11
    • GAMP 5
    • SDLC and custom software development
    • Computer Systems Validation (CSV), Computer Software Assurance (CSA) and modern validation methodologies
    • Familiarity with FDA regulations, as applicable to automated business processes
    • Familiarity with EU EMA regulations, as applicable to automated business processes
    • Data Integrity including ALCOA+
    • Experience with validation of Software in or as Medical Devices is a plus
  • Exceptional verbal and written communication skills, with the ability to present complex compliance concepts to senior-level stakeholders.
  • Strong analytical skills, with the ability to evaluate technical systems and recommend improvements that enhance compliance and data integrity, while considering business needs.
  • Experience in contributing to business development activities, including proposal framing, building strong client relationships, and identifying new IT compliance service opportunities.

Please note: This application may be reviewed in part by automated systems to help identify qualified candidates.

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