CSV Engineer; Computer System Validation

Overview

Location: Houston, TX and Waco, TX (Hybrid / Onsite – as required)

Duration: Long-term Contract

Industry: Biotech / Pharmaceutical / Life Sciences

We are 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.

This is a long-term contract opportunity supporting ongoing system implementations, upgrades, and compliance initiatives at our Houston-based facility.

• 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:
• URS / FRS / DS
• 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)

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 Val Genesis, Kneat, or similar platforms
• Experience working in pharmaceutical, biotech, or medical device industries
• Excellent communication and documentation skills

• 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 Track Wise

Primary Tool: particularly focusing on tools like Service Now (Or equivalent) Software for asset management, process standardization, and dashboard development

• Database Tools: SQL, APIs, ETL Tools (e.g., Informatica, Talend)
• Visualization Tools:
  Recommended Software Reporting, Power BI (if external visualization is required)
• Form Tools:
  Recommended Software Form Builder or third-party digital form solutions
• Process Tools: BPMN (Business Process Model and Notation) or equivalent process-mapping tools

• Recommended Software Asset Management Expertise
• Experience in implementing and customizing Recommended Software (Example: Service Now) 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.