CSV Engineer (Computer System Validation) jobs in United States
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Mastech Digital · 7 hours ago

CSV Engineer (Computer System Validation)

positionHouston, TX
timeContract
remoteOnsite
senioritySenior Level
date6+ years exp

Mastech Digital is a company specializing in the Biotech, Pharmaceutical, and Life Sciences industries, and they are seeking an experienced CSV Engineer. The role focuses on validating computerized systems for GxP-regulated manufacturing and laboratory systems, ensuring compliance with FDA and global regulatory requirements.

Information Technology
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
vivek shrivastava
linkedin

Responsibilities

Lead Computer System Validation (CSV) activities for GxP equipment and automation systems
Perform validation in compliance with 21 CFR Part 11, EU Annex 11, GAMP 5
Execute and/or review IQ, OQ, PQ for equipment and computerized systems
Develop and approve validation deliverables including:
Validation Plans & Reports
URS, FS, DS
Risk Assessments (FMEA)
Traceability Matrices
Support FAT / SAT execution and documentation
Validate PLC, SCADA, DCS, MES, and laboratory instrument systems
Review and assess control logic, alarms, interlocks, and data integrity controls
Ensure validated state through change control, deviation management, and periodic reviews
Partner with Engineering, Automation, Quality, and Manufacturing teams
Support regulatory inspections and audits (FDA, MHRA, EMA)

Qualification

CSV experienceGAMP 521 CFR Part 11EU Annex 11Data Integrity (ALCOA+)IQ/OQ/PQ executionFAT/SAT executionAutomation validationAudit-readiness skillsControl systems familiarityHardware-software integrationMES validation experienceCloud-connected equipmentFDA audit participationDocumentation skills

Required

6+ years of CSV experience in pharma/biotech
Hands-on experience with equipment and automation validation
Strong knowledge of GAMP 5
Strong knowledge of 21 CFR Part 11
Strong knowledge of EU Annex 11
Strong knowledge of Data Integrity (ALCOA+)
Experience executing IQ/OQ/PQ, FAT/SAT
Familiarity with control systems and hardware-software integration
Excellent documentation and audit-readiness skills

Preferred

MES validation experience
Cloud-connected equipment or historian systems
Exposure to CSA applied to automation
FDA audit participation

Company

Mastech Digital

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Mastech Digital provides IT associates in digital and mainstream technologies, Digital Transformation Services around Salesforce.com and SAP
dateFounded in 1986
location
Pittsburgh, Pennsylvania, USA
people-size1001-5000 employees
web-link
http://www.mastechdigital.com/

H1B Sponsorship

Mastech Digital has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (399)
2024 (496)
2023 (540)
2022 (947)
2021 (681)
2020 (751)

Funding

Current Stage
Public Company
Total Funding
unknown
2008-09-26IPO

Leadership Team

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Ashok Trivedi
Co-Founder & Co-Chairman

Recent News

PR Newswire
Mastech Digital Reports Third Quarter 2025 Results
2025-11-13
PR Newswire
Mastech Digital to Discuss Third Quarter Financial Results on November 12, 2025
2025-11-03
PR Newswire
Mastech Digital Reports 2% Sequential Revenue Growth for the Second Quarter of 2025
2025-08-13
Company data provided by crunchbase