Computer System Validation
hace 2 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 *****).- 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: $***** - $***** la horaHorario:- Turno de 8 horas
-
Software Validation Technician Sr
hace 2 semanas
Chihuahua, 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 Technician Sr
hace 2 semanas
Chihuahua, 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 Process Validation Protocols (IQ, Create/Execute Engineering Changes Orders- Write/Approve changes related to manufacturing documentation...
-
Software Assurance
hace 2 semanas
Chihuahua, México Vitesco Technologies A tiempo completoJob ID: *****- Location: Juarez, MXOVERVIEW:REQUERIMENTSBS 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 of...
-
Software Validation Engineer Ii
hace 2 semanas
Chihuahua, México Medtronic A tiempo completo**Careers that Change Lives**A Day in the LifeResponsibilities 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...
-
Packaging Engineer
hace 2 semanas
Chihuahua, México Bepc Inc A tiempo completoLooking 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-*****, ISO-*****- 21 CFR Part.820- NOM-241- Packaging Experience.- FFS -Multivac and Tiromat- Sealing...
-
Business System Analyst
hace 3 semanas
Chihuahua, México AutoZone A tiempo completo**Position Summary**:Analyzes, designs and develops technology-based information systems. Responsible for researching and formally documenting business processes and requirements, developing formal system specifications, defining unit and system testing, preparing systems documentation and implementing new or revised systems.**Responsibilities**:-...
-
Software Quality Assurance Specialist II
hace 2 semanas
Chihuahua, México jobr.pro A tiempo completoAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise...
-
Software Quality Assurance Specialist II
hace 2 semanas
Chihuahua, México jobr.pro A tiempo completoAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise...
-
Software Quality Assurance Specialist II
hace 2 semanas
Chihuahua, México jobr.pro A tiempo completoAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise...
-
Software Quality Assurance Specialist II
hace 2 semanas
Chihuahua, México Jabil A tiempo completoSoftware Quality Assurance Specialist II At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil...
