Empleos actuales relacionados con Computer System Validation - Ciudad Juarez - BEPC Inc.
-
Computer System Validation
hace 2 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...
-
Computer System Validation
hace 2 semanas
Ciudad de México, Ciudad de México Programming A tiempo completoWe Are Hiring: Computer System Validation (CSV) Specialists – Pharma IndustryWe are urgently seekingexperienced Computer System Validation (CSV) Specialiststo supportGCP/GLP regulatory compliancefor a leading pharmaceutical organization. If you have a strong background in validating systems withinregulated, GxP environments, this is a great opportunity to...
-
Validation Software Engineer
hace 4 semanas
Ciudad Juarez, México BEPC Inc A tiempo completoCAMSTAR - MES (Manufacturing Execution System).- CSV (Computer Software Validation)- Jira similar to MS Project.- English Advanced.- Punctual, Responsible, Teamwork.- Bachelor degree in Computer Systems or Engineering.Tipo de puesto: Tiempo completo, Por obra o tiempo determinadoHorario:- Lunes a viernesPrestaciones:- Seguro de vidaLugar de trabajo: Empleo...
-
Senior Computer System Validation Engineer
hace 7 días
Ciudad de México Takeda A tiempo completoBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Software Validation Technician
hace 2 semanas
Ciudad Juarez, México BEPC Inc A tiempo completoThis 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 1 semana
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...
-
Validation Engineer Senior
hace 5 días
Ciudad Juarez, México BEPC Inc A tiempo completoBEPC 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...
-
Validation Engineer Staff
hace 5 días
Ciudad Juarez, México BEPC Inc A tiempo completoBEPC 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...
-
Software Validation Technician Sr
hace 2 días
Ciudad Juarez, México BEPC Inc A tiempo completoThis 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 4 semanas
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 as...
Computer System Validation
hace 4 semanas
**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 determinadoDuración del contrato: 6 mesesSalario: $30.00 - $35.00 la horaHorario:- Turno de 8 horas
