CSV Engineer (Computer System Validation)

Job Title: CSV Engineer (Computer System Validation) Location: Houston, TX and Waco ,TX (Hybrid / Onsite – as required) Duration: Long-term Contract Industry: Biotech / Pharmaceutical / Life Sciences Job Summary 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. Key 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) Required Qualifications 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 / Nice to Have 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 Job Description: Primary Tool: particularly focusing on tools like ServiceNow (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 " Preferred Skills: • 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.