Mastech Digital · 20 hours ago
CSV Engineer (Computer System Validation)
Houston, TX
Contract
Hybrid
Senior Level
5+ years expMastech Digital is seeking an experienced Computer System Validation (CSV) Engineer to support validation activities for regulated GxP systems within a life sciences environment. The ideal candidate will have hands-on experience validating enterprise and laboratory systems, strong documentation skills, and the ability to collaborate closely with QA, IT, and business stakeholders.
Information Technology
Hiring Manager
vivek shrivastava
Responsibilities
Lead and execute CSV activities in compliance with FDA 21 CFR Part 11, GAMP 5, and applicable GxP regulations
Develop and maintain validation documentation including:
Validation Plans (VP / VMP)
URS / FRS / DS
Risk Assessments (FMEA)
IQ / OQ / PQ protocols and reports
Traceability Matrix (RTM)
Perform risk-based validation for new system implementations, upgrades, and changes
Validate systems such as:
LIMS, MES, ERP (SAP), QMS / eQMS
ELN, CDS, and other laboratory or manufacturing systems
Cloud and SaaS-based applications (as applicable)
Support change control, deviation management, and CAPA activities
Ensure data integrity principles (ALCOA+) are consistently applied
Partner with QA, IT, vendors, and business users throughout the system lifecycle
Provide support during regulatory inspections and audits (FDA, EMA, internal audits)
Qualification
Required
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
5+ years of hands-on Computer System Validation experience in a regulated environment
Strong knowledge of: 21 CFR Part 11
GxP (GMP, GLP, GCP)
GAMP 5
Data Integrity requirements
Proven experience authoring and executing validation documentation
Familiarity with validation tools such as ValGenesis, Kneat, or similar platforms
Experience working in pharmaceutical, biotech, or medical device industries
Excellent communication and documentation skills
Preferred
Experience with SAP validation (PP, QM, MM modules)
Cloud validation experience (AWS, Azure, regulated SaaS)
Prior experience supporting FDA or regulatory audits
Knowledge of quality systems such as Veeva Vault or TrackWise
Recommended Software Asset Management Expertise
Experience in implementing and customizing Recommended Software (Example: ServiceNow) Asset Management modules
Knowledge of CMDB (Configuration Management Database) for asset tracking and integration
Proficiency in workflows, reporting, and automation
Recommended Software Dashboard Development
Skills in building dynamic dashboards with data visualization features such as heat maps
Knowledge of integrating real-time data from external databases into software
Expertise in implementing drill-down menus and query-based search functionalities
Expertise in integrating Product Software with external databases like WebEOR, SEAM, and OSL via APIs, ETL tools, or data connectors
Proficiency in data cleaning, transformation, and consolidation from multiple sources
Skills in ensuring data integrity and consistency across systems
Strong knowledge of database systems, including SQL and non-SQL databases
Experience with database integration and querying tools
Expertise in using ETL (Extract, Transform, Load) tools to connect and process data between systems
Proficiency in ensuring real-time data synchronization
Company
Mastech Digital
Mastech Digital provides IT associates in digital and mainstream technologies, Digital Transformation Services around Salesforce.com and SAP
1001-5000 employees
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 CompanyTotal Funding
unknown2008-09-26IPO
Leadership Team
Ashok Trivedi
Co-Founder & Co-Chairman
Recent News
2025-11-13
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2025-08-13
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