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Computer System Validation Csv Jobs in Raleigh, NC

Orise

Senior MES Engineer

Raleigh, NC · On-site

$101K - $139K/yr

Required : • Bachelor's degree in Engineering, Computer Science, Information Systems, or a ... system validation, CSV, and regulated documentation practices • Knowledge of ISA-88 / ISA-95 ...

GRIFOLS, S.A.

Manufacturing Digital Manager

Clayton, NC · On-site

Strong experience with data integrity principles, computer system validation (CSV), and GxP regulations * Demonstrated experience implementing or sustaining EBR/MES platforms. Preferred * Experience ...

Corning

Division Quality Engineer I

Durham, NC

$69K - $89K/yr

Support the standardization of computer systems validation procedures, templates, and documentation ... Author, review, execute, and approve CSV lifecycle documentation, including: * Ensure computerized ...

PM Group

Site MES IT Coordinator

Zebulon, NC · On-site

Bachelor's degree in Engineering, Information Technology, Computer Science, Life Sciences, or a ... Familiarity with regulated manufacturing environments and computerized system validation (CSV ...

PM Group

Site MES IT Coordinator

Zebulon, NC

Familiarity with regulated manufacturing environments and computerized system validation (CSV ... Bachelor's degree in Engineering, Information Technology, Computer Science, Life Sciences, or a ...

Zifo

Principal CQV Consultant

Cary, NC · Hybrid

... and CSV to CSA approaches for lab/manufacturing systems (21 CFR Part 11, Annex 11, Data Integrity/ALCOA+). * Advise and guide onsite/remote validation consultants on qualification strategy ...

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

As of Jul 22, 2026, the average hourly pay for computer system validation csv in Raleigh, NC is $50.36, according to ZipRecruiter salary data. Most workers in this role earn between $37.84 and $62.64 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Computer System Validation Csv position, and why are they important?

To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.

What is a Computer System Validation (CSV) job?

A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.

What are some typical challenges faced by Computer System Validation professionals and how are they addressed?

Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

What are popular job titles related to Computer System Validation Csv jobs in Raleigh, NC? For Computer System Validation Csv jobs in Raleigh, NC, the most frequently searched job titles are:
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Computer System Validation Csv jobs near you
Infographic showing various Computer System Validation Csv job openings in Raleigh, NC as of July 2026, with employment types broken down into 78% Full Time, and 22% Contract. Highlights an 100% In-person job distribution, with an average salary of $104,739 per year, or $50.4 per hour.

System Administrator - MSAT Applications

FUJIFILM Biotechnologies

Holly Springs, NC • On-site

Full-time

Posted 28 days ago

Job description

Job Summary:
FUJIFILM Biotechnologies is focused on enabling data-driven manufacturing and development, and they are seeking a System Administrator for MSAT applications. This role involves owning, maintaining, and improving the analytics and real-time monitoring ecosystem while ensuring GxP systems are secure, validated, and highly available across global environments.
Responsibilities:
• Administer and support SIMCA-online, Statistica Server, and PAT platforms
• Manage Windows Server services, capacity, and uptime; tune performance and troubleshoot latency
• Maintain SQL Server/Oracle databases for configurations, results storage, and audit trails
• Integrate with DCS/SCADA (e.g., DeltaV), historians (e.g., OSIsoft PI/AVEVA), MES (e.g., Syncade), LIMS/ELN, and OPC UA/DA/MQTT gateways
• Manage data retention, archival, and restoration aligned to corporate data governance
• Ensure cGxP compliance, data integrity (ALCOA+), and security across integrations
• Partner with QA/CSV on risk-based validation (GAMP 5, CSA) and audit readiness
• Implement RBAC/least-privilege, AD/LDAP integration, and SSO where applicable
• Manage audit trails, e-signatures, certificates, vulnerability management, and patching within validated-state controls
• Lead incident/problem/change management; conduct root cause analysis and drive CAPAs
• Monitor connectors, job queues, and data flows; plan upgrades, patch cycles, and license/vendor management
• Implement and test backup/restore, business continuity, and disaster recovery
• Maintain complete and contemporaneous records of configurations, changes, and deviations
• Support internal/external audits and health authority inspections
Qualifications:
Required:
• Bachelor’s degree in Computer Science, Engineering, Scientific field, or equivalent practical experience
• 5+ years in IT systems administration, with 3+ years supporting MSAT or historian applications
• Experience with SIMCA-online, TIBCO Statistica, synTQ, AspenTech, and/or historian platforms
• Strong Windows Server and Active Directory administration; PowerShell scripting; SQL Server/Oracle fundamentals
• Experience with OSIsoft PI/AVEVA, OPC UA/DA, DCS/SCADA, MES, LIMS/ELN, and API/file-based integrations
• Practical knowledge of cGxP, data integrity (ALCOA+), Computer Systems Validation (CSV), GAMP 5, and CSA approaches
• Familiarity with ITIL-based change/incident/problem management and service operations
Preferred:
• Background in biopharma manufacturing or process development environments
• Experience designing secure architectures with SSO, certificates, and electronic signatures in validated systems
• Performance tuning, capacity planning, and proactive monitoring for real-time analytics platforms
Company:
For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine. Founded in 2011, the company is headquartered in Morrisville, USA, with a team of 1001-5000 employees. The company is currently Late Stage.

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