Computer System Validation

hace 3 días


Ciudad Juarez, México BEPC Inc. A tiempo completo

**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


  • Validation Engineer

    hace 7 meses


    Ciudad Juarez, México Invisibles Systems A tiempo completo

    **Education, Experience, Knowledge**: - Strong English skills verbally and written proficiency for documentation - Degree in Computer or Electrical Engineering - Previous experience as a validation engineer or in a similar role - Strong understanding of testing processes - Knowledge of firmware and software data flow and analysis - Excellent mathematical...


  • Ciudad Juarez, México BEPC Inc A tiempo completo

    BEPC has a Ciudad Juarez area OPEN POSITION for Validation engineer senior to join our fast-growing team of consultants! 3 to 5 years of experience in the Medical Industry. This role is responsible for creating, reviewing, executing, and summarizing validation protocols and providing input, critical review and approval of any related validation activities...


  • Ciudad Juarez, México BEPC Inc A tiempo completo

    BEPC has a Ciudad Juarez area OPEN POSITION for Validation engineer Staff to join our fast-growing team of consultants! 5 years of experience in the Medical Industry. This role is responsible for creating, reviewing, executing, and summarizing validation protocols and providing input, critical review and approval of any related validation activities...


  • Ciudad Juarez, México BEPC Inc A tiempo completo

    This role is responsible will be working on the shop floor to define the impact of the variant part and components, directly working with associates, group leaders and supervisors. **KEY RESPONSIBILITIES**: - Write/execute computer system validation protocols and completions reports - Write validation strategies, user requirements specifications, system...

  • Validation Engineer

    hace 6 meses


    Ciudad Juarez, México Trackonomy A tiempo completo

    **Join the Trackonomy Team!** At Trackonomy, our employee value proposition champions your growth through varied responsibilities and a commitment to innovation. Join us to evolve professionally in a company that reshapes both industries and individuals. **Connection & Community**: You're essential to Trackonomy's mission, and every team member is regarded...


  • Ciudad Juarez, México Flex A tiempo completo

    At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in...


  • Ciudad Juarez, México BEPC Inc A tiempo completo

    BEPC has a Ciudad Juarezarea OPEN POSITION for ValidationEngineerIII to join our fast-growing team of consultants! Contract Period: 6 months contract with opportunity for extension. BE/BS bachelor’s degree 3 years of medical devices experience. The Project Was Created to give Support to functional areas, engineers and / or technicians. Coordinate...


  • Ciudad Juarez, México Emprego MX A tiempo completo

    **EMPRESA IMPORTANTE** **Solicita**: **Engineering Lab Validation Manager** **Descripción y Requisitos** - The position requires a leader who can manage priorities, distribute resources across a portfolio of short/mid/long-term projects in the Validation Lab, and has experience working with different engineering teams. In this role also will be...


  • Ciudad Juarez, México Aptiv plc A tiempo completo

    **Position Summary** - Strong personnel coordination (engineers and technician levels), responsible for laboratory budget management: Capital and operational expenses management. Strong knowledge on product validation testing procedures and automotive industry standards. Strong experience with ISO 17025, ISO 14001 & IATF 16949. Advanced English & Spanish...


  • Ciudad Juarez, México BEPC Inc A tiempo completo

    This role is responsible will be working on the shop floor to define the impact of the variant part and components, directly working with associates, group leaders and supervisors. **KEY RESPONSIBILITIES**: - Write/Execute Process Validation Protocols (IQ, Create/Execute Engineering Changes Orders - Write/Approve changes related to manufacturing...

  • Software Technician

    hace 7 días


    Ciudad Juarez, México BUSINESS EXCELLENCE ´PROFESSIONAL CONSULTING A tiempo completo

    **Required Skills**: Highly proficient in Excel, Experience with data migration and script writing **Description** Assist with the implementation of a new software system for medical devices industry called EtQ. DUTIES: Writing UAT protocol and scripts to test system functionality Data Migration Mapping data from old system (SmartSolve) to new system (EtQ)...


  • Ciudad Juarez, México BEPC Inc A tiempo completo

    **_BEPC esta en busca de tecnico de validacion de software, egresados de carreras a fin pueden aplicar no experiência previa, pero si lo tiene es un plus._** **Description** Assist with the implementation of a new software system for Cordis called EtQ. DUTIES: Writing UAT protocol and scripts to test system functionality Data Migration Mapping data from...


  • Ciudad Juarez, México BEPC Inc A tiempo completo

    BEPC esta en busca de tecnico de validacion de software, egresados de carreras a fin pueden aplicar no experiência previa, pero si lo tiene es un plus. **Description** Assist with the implementation of a new software system for Cordis called EtQ. DUTIES: Writing UAT protocol and scripts to test system functionality Data Migration Mapping data from old...

  • Validation Analyst

    hace 7 meses


    Ciudad de México Thermo Fisher Scientific A tiempo completo

    reflect cost, time and alternative actions to satisfy existing and future needs of the corporation. Tests and evaluates plans and protocols for of system performance. Conducts analysis of systems specifications and uses the latest analysis/diagramming tools to represent business/technical processes. Develops conversion and system implementation plans....


  • Ciudad de México, Ciudad de México ConvaTec Inc. A tiempo completo

    ConvaTec Inc. is a global leader in medical products and technologies, dedicated to improving the lives of people around the world. We are seeking a highly skilled Senior Validation Consultant to join our team.About UsWe are a company with a rich history of innovation and commitment to quality. With a presence in almost 100 countries, we provide our products...


  • Ciudad Juarez, México Medtronic A tiempo completo

    **Careers that Change Lives **A Day in the Life Responsibilities may include the following and other duties may be assigned.- Design, Develop, Execute, Document and Implement all validations related to Software- Knowledge of manufacturing equipment software, PLC, HMI, etc.- Troubleshoot software/ equipment malfunctions- Write/Execute Process Validation...


  • Ciudad de México PQE Group A tiempo completo

    We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1500 employees, 45+ nationalities and 28 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues...

  • Software Assurance

    hace 2 días


    Ciudad Juarez, México Vitesco Technologies A tiempo completo

    Job ID: 24203- Location: Juarez, MXOVERVIEW: REQUERIMENTS BS on Digitals Systems, Electronics, Mechatronics, Information Technology or other related grade.Master degree is a plus '2 years or more years on developing automation software, system testing, auditing and implementing computer systems in a high demand manufacturing environment. 2 or more years...

  • Packaging Engineer

    hace 7 meses


    Ciudad Juarez, México BEPC Inc A tiempo completo

    Looking for a new opportunity in the medical device industry? BEPC INC in Juarez Chihuahua is hiring Validation Engineers! - CSV (Computer System Validation) experience - Strong Knowledge in UDI Requirements - Creation of IQ/OQ/PQ Protocols & Reports. - ISO-13485, ISO-11607 - 21 CFR Part. 820 - NOM-241 - Packaging Experience. - FFS -Multivac and Tiromat -...

  • Software Engineer

    hace 1 semana


    Ciudad Juarez, México Cordis A tiempo completo

    **Summary**: **Essential Functions and Responsibilities**: - Effectively identify and resolve complex system issues and appropriately communicates to management and stakeholders. - Act as an interface between the business, IT Outsourcing partners, and internal/external IT teams - Work with the business to interpret and gather requirements for IT Requests...