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**BEPC is looking for a Computer System Validation (CSV) Engineer in Cd. Juarez, Chih.** **Payr Rate : $30USD - $35USD / HR.** **Reports to** Supplier Auditing Account Manager/Division Director **JOB DESCRIPTION** CSV Engineer is responsible to ensure the technology solutions for GxP computerized systems developed by BEPC for customer requested computer systems are compliant to the expectations set forth in applicable US FDA computer system validation requirements and client specific procedural requirements. The CSV Engineer works with BEPC IT resources and client resources to complete associated CSV requirements and project documentation. The CSV engineer leads associated project management activities. **Responsibilities** - Determines the validation approach and managing all aspects of the Software Development Life Cycle (SDLC) approach based on the system classification for Computer System Validation projects. - Thorough understanding of the principles of computer systems validation, SDLC methodologies, and testing best practice incorporating the current thinking of US FDA’s Computer Software requirements. - Creation and/or maintenance of procedure or instruction development, document management concepts/processes, and support training delivery. - Facilitating and documenting risk assessments to system requirements (e.g. system classification, functional risk). - Responsible for ensuring personal and client Company compliance with all Federal, State, local and Company regulations, policies, and procedures. - Primary duty includes the exercise of discretion and independent judgment with respect to matters of significance. **Other Duties** Other duties may be assigned as required by BEPC management. **Competencies** - Knowledge in the US Code of Federal Regulation (CFR) and/or European Union (EU) regulations in medical device manufacturing, clinical or laboratory processes as they relate to Computer System Validation (e.g. 21 CFR Parts 11, 820, EU-Medical Device Regulation, ISO 13485). - Knowledge of requirements engineering, test environments and protocols, functional risk assessment, Installation/Operational Qualification and Performance Qualification, defect, and deviation management. - Familiarity with Architecture Standards and concepts, configuration diagrams, infrastructure topology and schematics. - Validation experience with computer systems (ERP, LIMS, QMS, ECM, LMS, etc) in the medical industry. - Use of Validation Lifecycle Management Systems (VLMS) preferred. **Supervisory Responsibility** This position is an individual contributor position. **Work Environment** This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers and smartphones. **Position Type/Expected Hours of Work** This is a full-time position, and hours of work typically Monday through Friday, 8:00 a.m. to 5:00 p.m. However, agility and quick response time to customer and employee requests may be required at other times to include evening and weekends. **Travel** Minimal (< 10%) travel is expected in this role. **Required Education and Experience** - A Bachelor’s degree in a technical/engineering discipline or equivalent experience - 5+ years of experience with FDA or EU standards and regulations in a process model for software development and computer system validation. Tipo de puesto: Tiempo completo, Por obra o tiempo determinado Duración del contrato: 6 meses Salario: $30.00 - $35.00 la hora Horario: - Turno de 8 horas
